Hiring: Manager – Regulatory Affairs (Pharma)

Location: Ahmedabad
Industry: Pharmaceutical
Qualification: B.Pharm / M.Pharm
Experience: 10–15 Years
Salary: ₹10–12 LPA
Joining: Immediate Joiners Preferred

Job Responsibilities:

- Prepare, compile, and review CTD/ACTD and country-specific dossiers for product registration and re-registration.
- Handle renewal and variation submissions as per regulatory guidelines.
- Review registration dossiers and respond to regulatory authority queries within timelines.
- Coordinate with R&D;, QA, QC, Production, and Stores for regulatory documentation.
- Manage FDA/DCGI documentation, including Manufacturing License, COPP, WHO-GMP, Free Sale Certificate, Product Permissions, etc.
- Review Drug Master Files (DMF), artwork, and GMP-related documentation.




- Track registration status and ensure timely completion of regulatory activities.
- Ensure compliance with regulatory requirements across export markets.

Requirements:

- B.Pharm or M.Pharm qualification.
- 10–15 years of experience in Pharmaceutical Regulatory Affairs.
- Robust knowledge of CTD/ACTD dossier preparation, FDA/DCGI regulations, and international regulatory submissions.
- Excellent coordination, documentation, and communication skills.

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Pay: ₹1,000,000.00 - ₹1,200,000.00 per year

Work Location: In person

📌 Regulatory Affairs Manager - Pharma Company - Ahmedabad
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