Regulatory Affairs Leader - Pharma (Canada)

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.
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