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 current 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 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.
Skills Required
- 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.