- 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.