Regulatory Executive - Canada

Role & responsibilities

• Support preparation of NDS, ANDS, DIN applications, amendments, and other applicable regulatory submissions for Canada market.
• Compile and review regulatory documentation and ensure submission content is complete, accurate, and consistent.
• Provide regulatory support to cross-functional teams.
• Handling of deficiency responses of Marketing Authorization Applications
• Communicate with partners for timely information availability
• Ensure timely submission of variation and commercial urgency requests to relevant regulatory authorities
• Maintenance of different project trackers
• Renewals and other applicable lifecycle activities

Preferred candidate profile

• 2 to 7 years of experience in Regulatory Affairs (RA), specifically in the Canadian market.
• Experience in pharmaceutical formulations.
• B.Pharm, M.Pharm, or any other relevant degree in Life Sciences or a related field.