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nasdaq:rare
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www.ultragenyx.com
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www.ultragenyx.com
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Dec 28th, 2018 12:00AM
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Medical Affairs Manager, Germany
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Open
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Medical Affairs
|
Berlin, Germany
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Berlin
|
|
DEU
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Dec 17th, 2018 12:00AM
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Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
JOB FUNCTION:
The Medical Affairs Manager is a newly created key function on the Ultragenyx team for Germany and neighbouring countries in Central Europe with paramount input into the future development of the local organization. The central responsibility of the incumbent is to develop and execute a local medical strategy with the purpose of supporting HCPs in delivering the best patient care in the therapeutic areas that Ultragenyx addresses by driving key scientific initiatives to improve the diagnostic and therapeutic standard of care in the best interest of affected patients and families. This includes education and dissemination of medical knowledge in highly specialized fields but also devising strategies that help the identification of patients as well as facilitating their access to treatment.
ACCOUNTABILITIES:
- Determine local Medical Affairs strategy in alignment with European Medical Team and plan resource allocation
- Provide scientific contribution into regional market access processes, including reimbursement dossier review, value communication to stakeholders and management of relations with professional societies, the local patient advocacy community and policy makers
- Analyze local environment to identify and prioritize KOLs and referral patterns as well as gaps in infrastructure for patient care and develop strategies to address the unmet medical need in patient diagnosis and care provision
- Support local scientific community in the dissemination of medical education, foster cross-functional networking, address and internally process requests for investigator-sponsored research and unsolicited compassionate use inquiries
- Develop strategic initiatives with the purpose of shaping policy making to the benefit of patient care. Provide operational oversight and coordinate execution of alliances with external partners (e.g. newborn screening)
- Provide support and act as main local contact for specific and umbrella patient advocacy organizations
- In cooperation with global Clinical Operations, identify potential local investigators, provide input into trial design from a local perspective. Support local execution and facilitate reporting of Disease Monitoring programs and clinical trials
- Interact with global Medical teams to contribute to international projects and guide their local execution, provide input on local data needs, especially in context of AMNOG and other reimbursement process
- Review disease education and promotion material and execute function of Information Officer according to German Pharmaceuticals Act §74
- Responsibility for local Medical Affairs budget drafting and monitoring
- Foster international collaboration of scientific community, organize participation in national scientific conventions and preceptorship programs
- Generate training material and help in the on-boarding and training of new colleagues
- Assist in the evaluation of new business opportunities by evaluating the treatment landscape and unmet medical need in the territory
- Address unsolicited requests for compassionate use from HCPs and internally process applications for grants
Key internal contacts
Local General Management / Market Access, European Medical Affairs Team, Global Medical Affairs Team, Drug Safety, Regulatory, Quality, Legal/Compliance, Finance, Clinical Operations
Key external contacts
KOLs, Scientific associations, patient advocacy groups, service providers (e.g. medical writers, medical education agencies, online platforms, translation agencies)
EDUCATION, EXPERIENCE, SKILLS, KNOWLEDGE
Education:
- Physician, Pharmacist or scientist with a university education in a relevant scientific field, B.Sc. minimal requirement
- Fluent written and spoken German and English mandatory. Knowledge of an Eastern European language is an asset
Experience:
- Minimum of 7 years of experience in pharmaceutical industry
- Experience in Orphan Drugs or highly specialized medical areas imperative – knowledge of at least 3 different medical specialties and established relationships to KOLs desirable. As a minimum, 3 years of KOL management on a national level required
- Launch experience required, direct involvement in AMNOG processes strongly preferred
- Outstanding insights into German health care system and the interactions and interdependencies of sick funds, KVs, MDK, IQWiG, GKV-SV and GBA with HCPs
- Thorough knowledge of local relevant laws and Pharmaceutical industry’s code of conduct, impeccable business integrity record
- Understanding of GCP and GDP standards
Skills:
- High level of energy, ambition and intellectual curiosity with the ability to rapidly digest and interpret new information
- Excellent communication skills in personal and remote (phone and online) interactions
- Discipline and self-motivation, ability to work autonomously and deliver against defined timelines
- Creativity and open-mindedness to pursue challenging objectives with little investment
- Resilience and organizational skills that allow completion of multiple competing tasks under stress
- Capable of working in a complex matrix environment
- Professional attitude with courtesy, respect and self-confidence and a priority for impeccable business integrity
- IT skills; competent with Microsoft Outlook, Word, Excel and PowerPoint
TRAVEL REQUIREMENTS
Frequent domestic and occasional international travel including overnight stays is required
Valid and clean driver's licence
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Dec 28th, 2018 02:31PM
|
Dec 28th, 2018 02:31PM
|
Ultragenyx Pharmaceutical
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Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:rare
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www.ultragenyx.com
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www.ultragenyx.com
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Sep 8th, 2018 12:00AM
|
Senior Director Regulatory Affairs, Europe
|
Open
|
|
Regulatory Affairs
|
Basel, Switzerland
|
Basel
|
|
CHE
|
Sep 3rd, 2018 12:00AM
|
|
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Sep 8th, 2018 11:13AM
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Sep 8th, 2018 11:13AM
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Ultragenyx Pharmaceutical
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Health Care
|
Pharmaceuticals & Biotechnology
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nasdaq:rare
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www.ultragenyx.com
|
www.ultragenyx.com
|
Sep 9th, 2018 12:00AM
|
Senior Director Regulatory Affairs, Europe
|
Open
|
|
Regulatory Affairs
|
Basel, Switzerland
|
Basel
|
|
CHE
|
Sep 3rd, 2018 12:00AM
|
|
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Sep 9th, 2018 11:06AM
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Sep 9th, 2018 11:06AM
|
Ultragenyx Pharmaceutical
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Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:rare
|
www.ultragenyx.com
|
www.ultragenyx.com
|
Sep 22nd, 2018 12:00AM
|
Senior Director Regulatory Affairs, Europe
|
Open
|
|
Regulatory Affairs
|
Basel, Switzerland
|
Basel
|
|
CHE
|
Sep 3rd, 2018 12:00AM
|
|
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Sep 22nd, 2018 09:16AM
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Sep 22nd, 2018 09:16AM
|
Ultragenyx Pharmaceutical
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Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:rare
|
www.ultragenyx.com
|
www.ultragenyx.com
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Sep 25th, 2018 12:00AM
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Senior Director Regulatory Affairs, Europe
|
Open
|
|
Regulatory Affairs
|
Basel, Switzerland
|
Basel
|
|
CHE
|
Sep 3rd, 2018 12:00AM
|
|
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Sep 25th, 2018 05:56AM
|
Sep 25th, 2018 05:56AM
|
Ultragenyx Pharmaceutical
|
Health Care
|
Pharmaceuticals & Biotechnology
|
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nasdaq:rare
|
www.ultragenyx.com
|
www.ultragenyx.com
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Sep 26th, 2018 12:00AM
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Senior Director Regulatory Affairs, Europe
|
Open
|
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Regulatory Affairs
|
Basel, Switzerland
|
Basel
|
|
CHE
|
Sep 3rd, 2018 12:00AM
|
|
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Sep 26th, 2018 06:19AM
|
Sep 26th, 2018 06:19AM
|
Ultragenyx Pharmaceutical
|
Health Care
|
Pharmaceuticals & Biotechnology
|
|
nasdaq:rare
|
www.ultragenyx.com
|
www.ultragenyx.com
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Oct 5th, 2018 12:00AM
|
Senior Director Regulatory Affairs, Europe
|
Open
|
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Regulatory Affairs
|
Basel, Switzerland
|
Basel
|
|
CHE
|
Sep 3rd, 2018 12:00AM
|
|
Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Oct 5th, 2018 07:12AM
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Oct 5th, 2018 07:12AM
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Ultragenyx Pharmaceutical
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:rare
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www.ultragenyx.com
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www.ultragenyx.com
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Oct 8th, 2018 12:00AM
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Senior Director Regulatory Affairs, Europe
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Open
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Regulatory Affairs
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Basel, Switzerland
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Basel
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CHE
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Sep 3rd, 2018 12:00AM
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Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Oct 8th, 2018 08:11AM
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Oct 8th, 2018 08:11AM
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Ultragenyx Pharmaceutical
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:rare
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www.ultragenyx.com
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www.ultragenyx.com
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Oct 11th, 2018 12:00AM
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Senior Director Regulatory Affairs, Europe
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Open
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Regulatory Affairs
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Basel, Switzerland
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Basel
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CHE
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Sep 3rd, 2018 12:00AM
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Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Position Summary
The Senior Director, Regulatory Affairs, Europe is responsible for leading the European regulatory function and for building a regulatory infrastructure to ensure regulatory support in all European countries. Key responsibilities include supporting all regulatory-related activities related to the launch of Ultragenyx commercial products in each of the Member States of the EU and for ensuring the implementation of post-marketing requirements following marketing authorization. In addition, the Senior Director provides strategic input to guide development and registration plans to support successful approval of Ultragenyx products in Europe. This position reports to the Global Head of Regulatory Affairs.
Responsibilities
· Leads the European regulatory function and builds a regulatory infrastructure to ensure regulatory support in all European countries (initially using regional CROs and consultants as necessary)
· Participates in the European leadership team and contributes to the plans for the region ensuring all regulatory requirements are met
· Leads regulatory-related launch and post-marketing activities in the EU:
- Provides regulatory input to market access strategy and HTA plans and submissions in the EU
- Ensures local regulatory requirements are fulfilled in each country
- Provides regional specific advice regarding post-marketing and promotional activities to legal, medical and regulatory review committees
- Reviews all promotional/disease awareness and internal training materials to ensure they meet requirements of the applicable EU Directives and national regulations
- Ensures product information is maintained in national databases
- Ensures all packaging and labeling requirements are met according to local requirements
- Ensures all post-marketing requirements and maintenance activities are met.
· Provides review and support for named patient sales/compassionate use programs in Europe
· Provides regulatory leadership and strategic guidance regarding European requirements for development and registration of Ultragenyx products:
- Acts as a bridge from the European Leadership team to the US Regulatory Affairs and the Development teams to ensure that Ultragenyx maximizes opportunities for European involvement in development activities
- Serves as a key advisor regarding European requirements
- Reviews key documents related to clinical development and registration of products and provide strategic input from a European regulatory perspective.
- Participates in meetings with European health authorities.
· Influences the European regulatory environment
- Identifies opportunities for influencing Health Authorities (via industry groups, regulatory network).
Requirements
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Specific requirements include but are not limited to:
· At least 10-12 years of experience in European Regulatory Affairs in the pharmaceutical/biotechnology industry.
· Bachelor of Science in a scientific discipline, MS or PhD preferred.
· Rare disease/orphan product experience is desirable.
· Strong knowledge of European regulations and requirements.
· Strong team player that has a customer service approach and is solution oriented.
· Ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
· Excellent attention to detail, written and verbal communication, and strong influencing and negotiating skills.
· Ability to prioritize and handle multiple projects simultaneously. Business travel to be ~10% as required.
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Oct 11th, 2018 07:32AM
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Oct 11th, 2018 07:32AM
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Ultragenyx Pharmaceutical
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Health Care
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Pharmaceuticals & Biotechnology
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nasdaq:rare
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www.ultragenyx.com
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www.ultragenyx.com
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Sep 13th, 2018 12:00AM
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Medical Science Liaison, Colombia
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Open
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Medical Affairs
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Bogata, Colombia
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Bogotá
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Bogota
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COL
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Sep 6th, 2018 12:00AM
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Why Join Us?
Be a hero for our rare disease patients
Ultragenyx is a biopharmaceutical company committed to developing treatments for rare and ultra-rare diseases. Founded in 2010, the company has rapidly built a diverse portfolio of small molecule, monoclonal antibody, mRNA and gene therapy candidates with the potential to address debilitating genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
Developing new treatments for rare genetic diseases is challenging work. It takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impact. At Ultragenyx we push each other to perform at our very best, because we never lose sight of our mission – to make a difference in our patients’ lives.
Come join our team during this exciting time of growth and opportunities!
Job Summary
ultraimpact – Make a difference for those who need it most
The MSL will serve as a scientific liaison to the medical/scientific community and will be responsible for establishing, developing and maintaining relationships with prominent physicians within a designated area.
The MSL will help to integrate the efforts of the Medical Affairs Department with R&D, Clinical Affairs and Scientific Affairs and with other internal teams to ensure effective selection and execution of investigator-initiated clinical trials. The incumbent will also provide clinical and educational support to managed care organizations, as well as identify influential senior clinicians on the national and regional level.
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Sep 13th, 2018 02:50PM
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Sep 13th, 2018 02:50PM
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Ultragenyx Pharmaceutical
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Health Care
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Pharmaceuticals & Biotechnology
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