Join our dedicated Regulatory department as a Regulatory Affairs Officer to enhance market authorization strategies for recent medicinal products. Your expertise will ensure essential compliance for life-saving products in Canada. We are seeking two professionals for important roles in our Regulatory team. As a Regulatory Affairs Officer, you'll lead new drug submissions and manage lifecycle maintenance, ensuring our products meet the highest safety standards. Engage directly with Health Canada's Health Products and Food Branch to resolve any queries and provide vital regulatory intelligence on food and drug regulations.
Key Responsibilities
• Author New Drug and Abbreviated Drug submissions in eCTD
• Interpret clinical trials for supporting efficacy claims
• Liaise with Health Canada during submission processes
• Ensure labeling meets Canadian regulatory standards
• Provide updates on Food and Drug Act changes
Requirements:
• Ph.
D., PharmD, or Master’s in relevant field
• RAC certification is an asset
• 4+ years in Canadian pharma regulations
• Knowledge of PAAB and Ad Standards
• Strong understanding of product compliance Elevate your career by leading regulatory strategies that protect patient health in the Canadian market.