Key Responsibilities:
- Evaluate proposed post-approval changes for approved biosimilar products by referring to appropriate guidance and regulations.
- Prepare assigned post-approval submissions for biosimilar products, including Notifiable Changes and Level III, as well as submissions for post-approval Pharmacovigilance and Quality activities.
- Prepare responses to Health Canada questions for assigned projects in a timely manner.
- Participate in the preparation of Supplemental New Drug Submissions and New Drug Submissions.
- Ensure documentation prepared in scope of assigned projects is accurately presented.
Candidate Profile:
- Exposure in the pharmaceutical industry with biologics, preferably in regulatory affairs for highly regulated markets.
- Demonstrated understanding of both CMC and clinical requirements.
- Hands-on experience with literature-based submissions (e.g., 505(b)(2), SRTD) is an added advantage.
How to Apply: Send your profile to sjani@jamppharma.com.