MPharma & MSc Pharmaceutical Sciences Jobs at Kesar Drugs Pvt. Ltd.
Drug Regulatory Affairs Manager at Kesar Drugs Pvt. Ltd.
Company: Kesar Drugs Pvt. Ltd.
Location: Panchkula, Haryana
Department: Regulatory Affairs
Position: Manager – Regulatory Affairs (Injectables)
Budget: Based on current CTC 5-15% hike
Qualification: M.Pharm / M.Sc. (Pharmaceutical Sciences / Regulatory Affairs or any field)
Experience: 2-4 years
Key Responsibilities:
- Prepare, review, and submit dossiers (CTD/ACTD) and regulatory filings for injectables to various authorities (DCGI, CDSCO, WHO, USFDA, EU, etc.).
- Ensure compliance with Drugs & Cosmetics Act, Schedule M, WHO-GMP, and international regulatory guidelines.
- Coordinate with R&D, QA, QC, Production, and Validation teams for regulatory documentation and audits.
- Handle new product registrations, license renewals, COPP, and post-approval variations.
- Liaise with regulatory authorities and external agencies for timely approvals and inspections.
- Manage and prepare documentation for plant audits, inspections (domestic & international), and regulatory queries.
- Monitor regulatory updates and communicate their impact on business operations.
- Lead and mentor the Regulatory Affairs team, ensuring compliance strategy and timely deliverables.
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. MPharma & MSc Pharmaceutical Sciences Jobs at Kesar Drugs Pvt. Ltd.
