Regulatory Affairs
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- Submission Leadership: Author and compile New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS) in eCTD format.
- Clinical Review: Interpret clinical trial data and pharmacovigilance reports to support safety and efficacy claims in dossiers.
- Agency Interaction: Act as the liaison with Health Canada’s Health Products and Food Branch (HPFB) to resolve Clarification Requests (Clarifax).
- Labeling Compliance: Ensure Product Monographs (PM) and Patient Medication Information (PMI) meet the latest Canadian plain language labeling requirements.
- Strategy: Provide regulatory intelligence on evolving Food and Drug Act amendments and their impact on our medicinal portfolio. Qualifications
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Education:
Ph.
D., PharmD, or Master’s in Toxicology, Pharmacology, or Chemistry.
- Certification: RAC (Regulatory Affairs Certification) is an asset.
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Experience:
4+ years in Canadian pharmaceutical regulatory affairs.
- Knowledge: Deep familiarity with PAAB (Physician's Advisory Board) and Ad Standards for medical advertising.
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