Regulatory Affairs & Compliance (Medicine/Pharma)

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 Canada’s Health Products and Food Branch (HPFB) to resolve Clarification Requests (Clarifax).
• Labeling Compliance: Ensure Product Monographs (PM) and Patient...