7 - 11 years
0 Lacs
Posted:1 week ago|
Platform:
On-site
Full Time
Role: AM/Manager Regulatory Affairs
Experience: 7-11 Years
Reporting: Head RA
Qualification: B.Pharm/M.Pharm
Job Location: Pune
Market : Canada
Dosage form: All types
1. Strong experience in Regulatory Affairs for Canada market.
2. To build regulatory strategy for submission, evaluation of changes and maintenance of product life-cycle for different dosage forms.
3. Compilation of NDS, ANDS Submissions.
4.Module-wise document review
5. Review of documents, artworks, ensuring documents align with eCTD (electronic Common Technical Document) guidelines.
6. Review of change controls
7. Gap analysis for new product filing.
8. Maintaining product Life cycle
9. Liaise with all cross functional departments for evaluation/approval of change proposal/deviations/escalation and their execution.
10. Internal guidance document preparation.
Emcure Pharmaceuticals Limited
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