Ph.D., PharmD, or Master's in Toxicology, Pharmacology, or Chemistry required.
Regulatory Affairs Certification (RAC) is advantageous but not mandatory.
Minimum of 4 years of experience in Canadian pharmaceutical regulatory affairs.
Strong understanding of PAAB and Ad Standards for medical advertising.
Knowledge of Canadian regulatory frameworks and product lifecycle management.
Responsibilities
Lead the submission process by authoring and compiling New Drug Submissions (NDS) and Abbreviated New Drug Submissions (ANDS) in eCTD format.
Interpret clinical trial data and pharmacovigilance reports to support safety and efficacy claims.
Act as a liaison with Health Canada's HPFB to address Clarification Requests (Clarifax).
Ensure compliance of Product Monographs (PM) and Patient Medication Information (PMI) with Canadian plain language labeling requirements.
Provide insights on changes to the Food and Drug Act and their effects on the medicinal product lineup.
Benefits
Opportunity to work on life-saving products impacting public health.
Collaborative work environment within a dedicated regulatory team.
Focus on professional growth and industry-related challenges.
Engagement with Health Canada for direct regulatory impact.
Contribution to meaningful change in the pharmaceutical sector.
Full Job Description
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 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.
