Posted:1 day ago|
Platform:
Work from Office
Full Time
Designation: Assistant Manager - Canada Market
Experience: 7-11 Years
Reporting: Head RA
Qualification: B.Pharm/M.Pharm
Job Location: Pune
Dosage form: All types
1. Strong experience in Regulatory Affairs for Canada or Europe market.
2. To build regulatory strategy for submission,evaluation of changes and maintenance of product life-cycle for different dosage forms.
3. Compilation of dossiers in CTD, eCTD.
4. Compilation and submission of queries and variations.
5. Regulatory compliance with Front offices and with Plant.
6. Review of documents, artworks
7. Review of change controls
8. Gap analysis for new product filing
9. Maintaining product Life cycle
10. Liaise with all cross functional departments for evaluation/approval of change proposal/deviations/escalation and their execution.
11. Internal guidance document preparation.
Looking forward for candidates having strong experience in Europe/Canada market
If relevant and interested pls share your profile.
Emcure
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