Job Title

Overview 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 new 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 Canadas 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 Masters 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. #J-18808-Ljbffr