Supervisor, Regulatory Affairs

November 28 2021
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Pharmacovigilance
Montreal, QC

Job Summary

This position, reporting to Vice President of Quality & Regulatory Affairs, is responsible for all aspects of regulatory affairs for submission of natural health products and therapeutic products applications and communication with regulators.

Principal Responsibilities

  • Supervise activities related to preparation of required documentation and submission of product applications to Health Canada (natural health products and therapeutic products) and respond to clarification requests from Health Canada and ensures product licenses are kept up-to-date through post-notice of compliance (NOC) changes request.
  • Prepare regulatory (ANDA) documents for submission to Health Canada using e-CTD FDA gateway.
  • Review regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
  • Review documents or materials for compliance with policies or regulations.
  • Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
  • Provide regulatory services (preparation of Drug and NHP submissions to Health Canada, etc.) for other companies on their behalf.
  • Communicate regulatory information to others and ensure that information is interpreted correctly.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Supervise pharmacovigilance activities on natural health products and therapeutic products including adverse drug reactions, literature search, annual summary report.
  • Establish procedures and systems for good documentation practices of regulatory filings either in hardcopy or electronic formats.
  • Prepare and maintain standard operating procedures related to Regulatory Affairs and Pharmacovigilance.
  • Takes part in product development/launch meetings to discuss regulatory implications and strategy as required.
  • Prepare staff schedules or work assignments.
  • Train staff in regulatory policies and procedures and conduct employee training programs.
  • Perform other duties as assigned by supervisor.

Requirements – Education

  • Bachelor's Degree in Life Sciences (e.g. Biochemistry, Biology, Molecular Medicine, Chemistry).
  • Master's Degree a definite asset.
  • DESS in Regulatory Affairs a definite asset.

Requirements – Experience

  • Minimum 10 years of experience in Regulatory Affairs within the pharmaceutical industry, in order to be able to work as independently as possible.

Requirements – Technical Know-How

  • Ability to provide quality work using strong organizational, facilitation and interpersonal skills in a cross-functional team internally and externally.
  • Knowledge of local, regional and any other relevant legislation and guidelines with regard to Regulatory (ICH, F&DA, WHO, USP/BP/EP, other), PV (e.g. ICH, CIOMS), in order to fulfill relevant (or supporting) duties. 
  • Proficient in electronic documentation, and regulatory software systems.
  • Application and enforcement of Euro-Pharm SOPs.
  • Enhance and maintain an awareness of the quality (Chemistry, Manufacturing and Controls) and safety/efficacy profile of Euro-Pharm products (marketed or investigational).
  • Ability to review relevant source documentation with attention to detail and accuracy, while managing multiple tasks and prioritizing work in order to meet strict deadlines.
  • Utilize effective problem-solving approaches to solve Regulatory and PV (supportive) issues, while seeking endorsement from Director when necessary.

Other Criteria

  • Fluency in both in English and French, written and oral. Communication with the Health Authorities and the personnel requires superior proficiency in both languages. This skill is also indispensable for submissions and labeling.
  • Computer literacy and working knowledge of MS Office suite and PDF editor.
  • Management skills: as they relate to roles and responsibilities, vis à vis timelines and internal/external collaborators.
  • Communication skills: Must be able to communicate efficiently with his/her colleagues and external stakeholders.
  • Results and quality oriented and understand the importance of deadlines.
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