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7 - 12 years
9.0 - 13.0 Lacs P.A.
Mumbai
Posted:2 months ago| Platform: 
Work from Office
Full Time
Looking candidates for Regulatory Affairs-South Africa Market Experience : 7 -13 Years Job Location: Andheri Mumbai Qualification: M. Pharm/ B.PHARM+PG IN RA Job Description: 1. Management of product lifecycle for South Africa Market. 2. Dossier Preparation 3. Query Response 4. Post Approval changes 5. Variation Filing 6. Coordination with cross functional team 7. Module 1-5 8. Preparation and compilation of administrative, quality & Safety application (Eg. Type IA,IB Type II) 9. Reviewing Product information as per QRD Requirement 10. Should have strong knowledge of CTD dossier and must have experience of team handling. 11. Risk Assessment and Mitigation: - Identify potential regulatory risks, develop mitigation plans and adapt strategies accordingly to minimize risks. 12. Provide regulatory guidance and support to other departments as needed. Thanks & Regards Mayuri
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