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Ticker Symbol Entity Name Domain As Of Date Title URL Brand Category Location Text City State Country Posted Date Number of Openings Description Date Added Date Updated GICS Sector GICS Industry
nasdaq:endp www.endo.com www.endo.com Nov 20th, 2019 12:00AM Manager, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Oct 22nd, 2019 12:00AM Manager, Regulatory Affairs Position Summary The Manager, Regulatory Affairs evolves in an environment where priorities are rapidly changing and must manage multiple projects simultaneously. He is responsible for the timely approval and regulatory maintenance of products. He participates to numerous regulatory projects while managing a team of 1 to 3 people. He must be able to handle multiple priorities and projects, adapt to a changing environment and have the capacity to take action rapidly while dealing with ambiguity. Reports ToAssociate Director, Regulatory Affairs Specific Responsibilities Prepare high quality regulatory submissions for prescription and non-prescription drugs, natural health products, biologics and medical devices: Evaluate data (chemistry/manufacturing, clinical, non-clinical, labeling), prepare CTD summaries (clinical, non-clinical and CMC), author Product monographs/package inserts, design of labels; Ensure project coordination of submissions;Liaise with Health Canada and partners during preparation and review of the submissions; Assemble and compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).Ensure liaison with Health Canada for specific regulatory matters including preparation of meetings with the Agency;Ensure that the various databases and post-approval activities related to regulatory submissions are kept up-to-date according to departmental procedures;Ensure that daily regulatory activities related to product life cycle are in compliance with the Canadian regulations and all relevant guidelines and policies;Supervise 1 to 3 employees:Provide support with coaching and mentoring;Manage the planning, preparation and coordination of direct reports submissions ensuring scheduled timelines are met; Review direct reports submissions to ensure Health Canada standards are met.Provide regulatory advice and support to other departments when needed. Characteristics of a Good Candidate Strong project management skills and be highly organized; Proven management skills;Ability to adapt to changing priorities / priority setting;Excellent communication and proven negotiation skills;Ability to effectively work in a team environment / strong interpersonal skills;Ability to work independently in a fast paced environment;Strong problem solving skills;Ability to understand regulatory issues and evaluate risk/requirements; Good regulatory strategic thinking;Good writing and communication skills in English;Bilingual in both official languages (English and French). Candidate ProfileExperience, Training and EducationRequired M.Sc. in Life Sciences or DESS in drug development;Minimum of 5 years in the Canadian regulatory field within the pharmaceutical industry; Experience in the preparation of electronic submissions;Strong background in both fields: clinical and Chemistry, Manufacturing, Controls (CMC);Excellent knowledge in Canadian regulations/guidelines as well as ability to interpret policies and guidelines for pharmaceuticals, biologics, medical devices and Natural Health Products;Strong scientific knowledge; Strong Microsoft Office skills;Good knowledge of drug development process. Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 20th, 2019 03:29AM Nov 20th, 2019 03:29AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 20th, 2019 12:00AM Associate, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Nov 15th, 2019 12:00AM Associate, Regulatory Affairs Position SummaryThe main responsibility of the Associate, Regulatory Affairs is to participate to the timely approval and regulatory maintenance of products. He also contributes to various regulatory projects.   Reports ToManager, Regulatory Affairs Specific Responsibilities Evaluate scientific data supporting post-approval changes against the Canadian regulations as well as all relevant guidelines and policies:       Prepare and submit files, such as annual notifications, in eCTD format;       Prepare accurate record of changes and ensure appropriate data/documentation is archived;Provide support and participate in the preparation of high quality submissions for prescription, non-prescription, natural health products, biologics and medical devices, as applicable:       Participate in the evaluation of scientific data (CMC) and preparation of submissions (including product monograph or labeling update) according to Canadian regulation and all relevant guidelines and policies;       Assemble, compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink); Review product labels to ensure compliance with Canadian regulations; Ensure that the various internal RA databases, archiving and post-approval activities related to regulatory submissions are maintained according to the departmental procedures; Communicate with external partners to obtain documentation (including GMP evidence, clinical data, etc.) necessary for RA dossiers. Characteristics of a Good Candidate Thoroughness & attention to detail; Scientific knowledge; Autonomy / Problem Solving; Communication; Sense of organization;Enthusiasm and desire to learn;Ability to adapt to changing priorities / Priority setting. Candidate ProfileExperience, Training and EducationRequiredBachelor degree in life science or equivalent;Minimum of 1-2 years in the Canadian regulatory field within the pharmaceutical industry;Knowledge of the Canadian regulations/guidelines; Bilingualism;Good writing and communication skills in English;Good knowledge of Microsoft Office Suite. AssetDESS in drug development;Good knowledge of drug development process and pharmaceutical business.Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 20th, 2019 03:29AM Nov 20th, 2019 03:29AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 21st, 2019 12:00AM Manager, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Oct 22nd, 2019 12:00AM Manager, Regulatory Affairs Position Summary The Manager, Regulatory Affairs evolves in an environment where priorities are rapidly changing and must manage multiple projects simultaneously. He is responsible for the timely approval and regulatory maintenance of products. He participates to numerous regulatory projects while managing a team of 1 to 3 people. He must be able to handle multiple priorities and projects, adapt to a changing environment and have the capacity to take action rapidly while dealing with ambiguity. Reports ToAssociate Director, Regulatory Affairs Specific Responsibilities Prepare high quality regulatory submissions for prescription and non-prescription drugs, natural health products, biologics and medical devices: Evaluate data (chemistry/manufacturing, clinical, non-clinical, labeling), prepare CTD summaries (clinical, non-clinical and CMC), author Product monographs/package inserts, design of labels; Ensure project coordination of submissions;Liaise with Health Canada and partners during preparation and review of the submissions; Assemble and compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).Ensure liaison with Health Canada for specific regulatory matters including preparation of meetings with the Agency;Ensure that the various databases and post-approval activities related to regulatory submissions are kept up-to-date according to departmental procedures;Ensure that daily regulatory activities related to product life cycle are in compliance with the Canadian regulations and all relevant guidelines and policies;Supervise 1 to 3 employees:Provide support with coaching and mentoring;Manage the planning, preparation and coordination of direct reports submissions ensuring scheduled timelines are met; Review direct reports submissions to ensure Health Canada standards are met.Provide regulatory advice and support to other departments when needed. Characteristics of a Good Candidate Strong project management skills and be highly organized; Proven management skills;Ability to adapt to changing priorities / priority setting;Excellent communication and proven negotiation skills;Ability to effectively work in a team environment / strong interpersonal skills;Ability to work independently in a fast paced environment;Strong problem solving skills;Ability to understand regulatory issues and evaluate risk/requirements; Good regulatory strategic thinking;Good writing and communication skills in English;Bilingual in both official languages (English and French). Candidate ProfileExperience, Training and EducationRequired M.Sc. in Life Sciences or DESS in drug development;Minimum of 5 years in the Canadian regulatory field within the pharmaceutical industry; Experience in the preparation of electronic submissions;Strong background in both fields: clinical and Chemistry, Manufacturing, Controls (CMC);Excellent knowledge in Canadian regulations/guidelines as well as ability to interpret policies and guidelines for pharmaceuticals, biologics, medical devices and Natural Health Products;Strong scientific knowledge; Strong Microsoft Office skills;Good knowledge of drug development process. Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 21st, 2019 04:41AM Nov 21st, 2019 04:41AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 21st, 2019 12:00AM Associate, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Nov 15th, 2019 12:00AM Associate, Regulatory Affairs Position SummaryThe main responsibility of the Associate, Regulatory Affairs is to participate to the timely approval and regulatory maintenance of products. He also contributes to various regulatory projects.   Reports ToManager, Regulatory Affairs Specific Responsibilities Evaluate scientific data supporting post-approval changes against the Canadian regulations as well as all relevant guidelines and policies:       Prepare and submit files, such as annual notifications, in eCTD format;       Prepare accurate record of changes and ensure appropriate data/documentation is archived;Provide support and participate in the preparation of high quality submissions for prescription, non-prescription, natural health products, biologics and medical devices, as applicable:       Participate in the evaluation of scientific data (CMC) and preparation of submissions (including product monograph or labeling update) according to Canadian regulation and all relevant guidelines and policies;       Assemble, compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink); Review product labels to ensure compliance with Canadian regulations; Ensure that the various internal RA databases, archiving and post-approval activities related to regulatory submissions are maintained according to the departmental procedures; Communicate with external partners to obtain documentation (including GMP evidence, clinical data, etc.) necessary for RA dossiers. Characteristics of a Good Candidate Thoroughness & attention to detail; Scientific knowledge; Autonomy / Problem Solving; Communication; Sense of organization;Enthusiasm and desire to learn;Ability to adapt to changing priorities / Priority setting. Candidate ProfileExperience, Training and EducationRequiredBachelor degree in life science or equivalent;Minimum of 1-2 years in the Canadian regulatory field within the pharmaceutical industry;Knowledge of the Canadian regulations/guidelines; Bilingualism;Good writing and communication skills in English;Good knowledge of Microsoft Office Suite. AssetDESS in drug development;Good knowledge of drug development process and pharmaceutical business.Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 21st, 2019 04:41AM Nov 21st, 2019 04:41AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 22nd, 2019 12:00AM Manager, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Oct 22nd, 2019 12:00AM Manager, Regulatory Affairs Position Summary The Manager, Regulatory Affairs evolves in an environment where priorities are rapidly changing and must manage multiple projects simultaneously. He is responsible for the timely approval and regulatory maintenance of products. He participates to numerous regulatory projects while managing a team of 1 to 3 people. He must be able to handle multiple priorities and projects, adapt to a changing environment and have the capacity to take action rapidly while dealing with ambiguity. Reports ToAssociate Director, Regulatory Affairs Specific Responsibilities Prepare high quality regulatory submissions for prescription and non-prescription drugs, natural health products, biologics and medical devices: Evaluate data (chemistry/manufacturing, clinical, non-clinical, labeling), prepare CTD summaries (clinical, non-clinical and CMC), author Product monographs/package inserts, design of labels; Ensure project coordination of submissions;Liaise with Health Canada and partners during preparation and review of the submissions; Assemble and compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).Ensure liaison with Health Canada for specific regulatory matters including preparation of meetings with the Agency;Ensure that the various databases and post-approval activities related to regulatory submissions are kept up-to-date according to departmental procedures;Ensure that daily regulatory activities related to product life cycle are in compliance with the Canadian regulations and all relevant guidelines and policies;Supervise 1 to 3 employees:Provide support with coaching and mentoring;Manage the planning, preparation and coordination of direct reports submissions ensuring scheduled timelines are met; Review direct reports submissions to ensure Health Canada standards are met.Provide regulatory advice and support to other departments when needed. Characteristics of a Good Candidate Strong project management skills and be highly organized; Proven management skills;Ability to adapt to changing priorities / priority setting;Excellent communication and proven negotiation skills;Ability to effectively work in a team environment / strong interpersonal skills;Ability to work independently in a fast paced environment;Strong problem solving skills;Ability to understand regulatory issues and evaluate risk/requirements; Good regulatory strategic thinking;Good writing and communication skills in English;Bilingual in both official languages (English and French). Candidate ProfileExperience, Training and EducationRequired M.Sc. in Life Sciences or DESS in drug development;Minimum of 5 years in the Canadian regulatory field within the pharmaceutical industry; Experience in the preparation of electronic submissions;Strong background in both fields: clinical and Chemistry, Manufacturing, Controls (CMC);Excellent knowledge in Canadian regulations/guidelines as well as ability to interpret policies and guidelines for pharmaceuticals, biologics, medical devices and Natural Health Products;Strong scientific knowledge; Strong Microsoft Office skills;Good knowledge of drug development process. Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 22nd, 2019 04:23AM Nov 22nd, 2019 04:23AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 22nd, 2019 12:00AM Associate, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Nov 15th, 2019 12:00AM Associate, Regulatory Affairs Position SummaryThe main responsibility of the Associate, Regulatory Affairs is to participate to the timely approval and regulatory maintenance of products. He also contributes to various regulatory projects.   Reports ToManager, Regulatory Affairs Specific Responsibilities Evaluate scientific data supporting post-approval changes against the Canadian regulations as well as all relevant guidelines and policies:       Prepare and submit files, such as annual notifications, in eCTD format;       Prepare accurate record of changes and ensure appropriate data/documentation is archived;Provide support and participate in the preparation of high quality submissions for prescription, non-prescription, natural health products, biologics and medical devices, as applicable:       Participate in the evaluation of scientific data (CMC) and preparation of submissions (including product monograph or labeling update) according to Canadian regulation and all relevant guidelines and policies;       Assemble, compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink); Review product labels to ensure compliance with Canadian regulations; Ensure that the various internal RA databases, archiving and post-approval activities related to regulatory submissions are maintained according to the departmental procedures; Communicate with external partners to obtain documentation (including GMP evidence, clinical data, etc.) necessary for RA dossiers. Characteristics of a Good Candidate Thoroughness & attention to detail; Scientific knowledge; Autonomy / Problem Solving; Communication; Sense of organization;Enthusiasm and desire to learn;Ability to adapt to changing priorities / Priority setting. Candidate ProfileExperience, Training and EducationRequiredBachelor degree in life science or equivalent;Minimum of 1-2 years in the Canadian regulatory field within the pharmaceutical industry;Knowledge of the Canadian regulations/guidelines; Bilingualism;Good writing and communication skills in English;Good knowledge of Microsoft Office Suite. AssetDESS in drug development;Good knowledge of drug development process and pharmaceutical business.Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 22nd, 2019 04:23AM Nov 22nd, 2019 04:23AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 24th, 2019 12:00AM Manager, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Oct 22nd, 2019 12:00AM Manager, Regulatory Affairs Position Summary The Manager, Regulatory Affairs evolves in an environment where priorities are rapidly changing and must manage multiple projects simultaneously. He is responsible for the timely approval and regulatory maintenance of products. He participates to numerous regulatory projects while managing a team of 1 to 3 people. He must be able to handle multiple priorities and projects, adapt to a changing environment and have the capacity to take action rapidly while dealing with ambiguity. Reports ToAssociate Director, Regulatory Affairs Specific Responsibilities Prepare high quality regulatory submissions for prescription and non-prescription drugs, natural health products, biologics and medical devices: Evaluate data (chemistry/manufacturing, clinical, non-clinical, labeling), prepare CTD summaries (clinical, non-clinical and CMC), author Product monographs/package inserts, design of labels; Ensure project coordination of submissions;Liaise with Health Canada and partners during preparation and review of the submissions; Assemble and compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).Ensure liaison with Health Canada for specific regulatory matters including preparation of meetings with the Agency;Ensure that the various databases and post-approval activities related to regulatory submissions are kept up-to-date according to departmental procedures;Ensure that daily regulatory activities related to product life cycle are in compliance with the Canadian regulations and all relevant guidelines and policies;Supervise 1 to 3 employees:Provide support with coaching and mentoring;Manage the planning, preparation and coordination of direct reports submissions ensuring scheduled timelines are met; Review direct reports submissions to ensure Health Canada standards are met.Provide regulatory advice and support to other departments when needed. Characteristics of a Good Candidate Strong project management skills and be highly organized; Proven management skills;Ability to adapt to changing priorities / priority setting;Excellent communication and proven negotiation skills;Ability to effectively work in a team environment / strong interpersonal skills;Ability to work independently in a fast paced environment;Strong problem solving skills;Ability to understand regulatory issues and evaluate risk/requirements; Good regulatory strategic thinking;Good writing and communication skills in English;Bilingual in both official languages (English and French). Candidate ProfileExperience, Training and EducationRequired M.Sc. in Life Sciences or DESS in drug development;Minimum of 5 years in the Canadian regulatory field within the pharmaceutical industry; Experience in the preparation of electronic submissions;Strong background in both fields: clinical and Chemistry, Manufacturing, Controls (CMC);Excellent knowledge in Canadian regulations/guidelines as well as ability to interpret policies and guidelines for pharmaceuticals, biologics, medical devices and Natural Health Products;Strong scientific knowledge; Strong Microsoft Office skills;Good knowledge of drug development process. Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 24th, 2019 03:42AM Nov 24th, 2019 03:42AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 24th, 2019 12:00AM Associate, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Nov 15th, 2019 12:00AM Associate, Regulatory Affairs Position SummaryThe main responsibility of the Associate, Regulatory Affairs is to participate to the timely approval and regulatory maintenance of products. He also contributes to various regulatory projects.   Reports ToManager, Regulatory Affairs Specific Responsibilities Evaluate scientific data supporting post-approval changes against the Canadian regulations as well as all relevant guidelines and policies:       Prepare and submit files, such as annual notifications, in eCTD format;       Prepare accurate record of changes and ensure appropriate data/documentation is archived;Provide support and participate in the preparation of high quality submissions for prescription, non-prescription, natural health products, biologics and medical devices, as applicable:       Participate in the evaluation of scientific data (CMC) and preparation of submissions (including product monograph or labeling update) according to Canadian regulation and all relevant guidelines and policies;       Assemble, compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink); Review product labels to ensure compliance with Canadian regulations; Ensure that the various internal RA databases, archiving and post-approval activities related to regulatory submissions are maintained according to the departmental procedures; Communicate with external partners to obtain documentation (including GMP evidence, clinical data, etc.) necessary for RA dossiers. Characteristics of a Good Candidate Thoroughness & attention to detail; Scientific knowledge; Autonomy / Problem Solving; Communication; Sense of organization;Enthusiasm and desire to learn;Ability to adapt to changing priorities / Priority setting. Candidate ProfileExperience, Training and EducationRequiredBachelor degree in life science or equivalent;Minimum of 1-2 years in the Canadian regulatory field within the pharmaceutical industry;Knowledge of the Canadian regulations/guidelines; Bilingualism;Good writing and communication skills in English;Good knowledge of Microsoft Office Suite. AssetDESS in drug development;Good knowledge of drug development process and pharmaceutical business.Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 24th, 2019 03:42AM Nov 24th, 2019 03:42AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 25th, 2019 12:00AM Manager, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Oct 22nd, 2019 12:00AM Manager, Regulatory Affairs Position Summary The Manager, Regulatory Affairs evolves in an environment where priorities are rapidly changing and must manage multiple projects simultaneously. He is responsible for the timely approval and regulatory maintenance of products. He participates to numerous regulatory projects while managing a team of 1 to 3 people. He must be able to handle multiple priorities and projects, adapt to a changing environment and have the capacity to take action rapidly while dealing with ambiguity. Reports ToAssociate Director, Regulatory Affairs Specific Responsibilities Prepare high quality regulatory submissions for prescription and non-prescription drugs, natural health products, biologics and medical devices: Evaluate data (chemistry/manufacturing, clinical, non-clinical, labeling), prepare CTD summaries (clinical, non-clinical and CMC), author Product monographs/package inserts, design of labels; Ensure project coordination of submissions;Liaise with Health Canada and partners during preparation and review of the submissions; Assemble and compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).Ensure liaison with Health Canada for specific regulatory matters including preparation of meetings with the Agency;Ensure that the various databases and post-approval activities related to regulatory submissions are kept up-to-date according to departmental procedures;Ensure that daily regulatory activities related to product life cycle are in compliance with the Canadian regulations and all relevant guidelines and policies;Supervise 1 to 3 employees:Provide support with coaching and mentoring;Manage the planning, preparation and coordination of direct reports submissions ensuring scheduled timelines are met; Review direct reports submissions to ensure Health Canada standards are met.Provide regulatory advice and support to other departments when needed. Characteristics of a Good Candidate Strong project management skills and be highly organized; Proven management skills;Ability to adapt to changing priorities / priority setting;Excellent communication and proven negotiation skills;Ability to effectively work in a team environment / strong interpersonal skills;Ability to work independently in a fast paced environment;Strong problem solving skills;Ability to understand regulatory issues and evaluate risk/requirements; Good regulatory strategic thinking;Good writing and communication skills in English;Bilingual in both official languages (English and French). Candidate ProfileExperience, Training and EducationRequired M.Sc. in Life Sciences or DESS in drug development;Minimum of 5 years in the Canadian regulatory field within the pharmaceutical industry; Experience in the preparation of electronic submissions;Strong background in both fields: clinical and Chemistry, Manufacturing, Controls (CMC);Excellent knowledge in Canadian regulations/guidelines as well as ability to interpret policies and guidelines for pharmaceuticals, biologics, medical devices and Natural Health Products;Strong scientific knowledge; Strong Microsoft Office skills;Good knowledge of drug development process. Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 25th, 2019 03:30AM Nov 25th, 2019 03:30AM Health Care Pharmaceuticals & Biotechnology
nasdaq:endp www.endo.com www.endo.com Nov 25th, 2019 12:00AM Associate, Regulatory Affairs Open Quality & Regulatory Affairs Montréal, Canada Montreal QC CAN Nov 15th, 2019 12:00AM Associate, Regulatory Affairs Position SummaryThe main responsibility of the Associate, Regulatory Affairs is to participate to the timely approval and regulatory maintenance of products. He also contributes to various regulatory projects.   Reports ToManager, Regulatory Affairs Specific Responsibilities Evaluate scientific data supporting post-approval changes against the Canadian regulations as well as all relevant guidelines and policies:       Prepare and submit files, such as annual notifications, in eCTD format;       Prepare accurate record of changes and ensure appropriate data/documentation is archived;Provide support and participate in the preparation of high quality submissions for prescription, non-prescription, natural health products, biologics and medical devices, as applicable:       Participate in the evaluation of scientific data (CMC) and preparation of submissions (including product monograph or labeling update) according to Canadian regulation and all relevant guidelines and policies;       Assemble, compile regulatory files in eCTD format, when applicable. Includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink); Review product labels to ensure compliance with Canadian regulations; Ensure that the various internal RA databases, archiving and post-approval activities related to regulatory submissions are maintained according to the departmental procedures; Communicate with external partners to obtain documentation (including GMP evidence, clinical data, etc.) necessary for RA dossiers. Characteristics of a Good Candidate Thoroughness & attention to detail; Scientific knowledge; Autonomy / Problem Solving; Communication; Sense of organization;Enthusiasm and desire to learn;Ability to adapt to changing priorities / Priority setting. Candidate ProfileExperience, Training and EducationRequiredBachelor degree in life science or equivalent;Minimum of 1-2 years in the Canadian regulatory field within the pharmaceutical industry;Knowledge of the Canadian regulations/guidelines; Bilingualism;Good writing and communication skills in English;Good knowledge of Microsoft Office Suite. AssetDESS in drug development;Good knowledge of drug development process and pharmaceutical business.Note: The use of the masculine gender includes the feminine and is employed solely to facilitate reading.Only selected candidates will be contacted. Nov 25th, 2019 03:30AM Nov 25th, 2019 03:30AM Health Care Pharmaceuticals & Biotechnology

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