The JAMP group is a proud Canadian owned company with its international headquarters located in Boucherville, 20 minutes from downtown Montreal, Quebec, Canada. The JAMP Pharma Group is active in all sectors of the pharmaceutical industry with our JAMP Pharma Generics, Orimed branded products, our Wampole and Laboratoire Suisse natural health supplements and our Cosmetic Import beauty and personal care products. The JAMP Pharma Group has also made a major investment in biosimilars which is one of the fastest growing markets in the pharmaceutical industry.
HIRING Regulatory Affairs (biosimilars) Assistant Manager / Deputy Manager
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
• Candidates with exposure in the pharmaceutical industry with biologics, preferably in regulatory affairs for highly regulated markets.
• Demonstrated understanding of both CMC and clinical requirements is needed.
• Hands-on experience with literature-based submissions (e.g., 505(b)(2), SRTD) is an added advantage.
Additional Information
Department : Regulatory Affairs (Biosimilars)
Experience : 6 - 10 years
Qualification : M.Pharm / M.Sc
Location : Ahmedabad
Send profile at sjani@jamppharma.com or Apply Online
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