Regulatory Affairs & Compliance (MedicinePharma)

Mississauga - Canada

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

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.

Skills Required:

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 (Physicians Advisory Board) and Ad Standards for medical advertising.

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 maintena...