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Job Title


Assistant Manager/ Manager Regulatory Affairs


Company : Emcure Pharmaceuticals Limited


Location : Pune, Maharashtra


Created : 2025-07-20


Job Type : Full Time


Job Description

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.