Job Brief: We are looking for two dedicated professionals to join our Regulatory department. As a Regulatory Affairs Officer , you will drive our market authorization strategy for recent medicinal products. As a Regulatory Officer , you will manage the essential operational compliance and lifecycle maintenance that keeps our life-saving products on the Canadian market.
Responsibilities
Submission Leadership: Author and compile Current Drug Submissions (NDS) and Abbreviated Recent 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
Education: Ph.D., PharmD, or Master’s in Toxicology, Pharmacology, or Chemistry.
Certification: RAC (Regulatory Affairs Certification) is an asset.
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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