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.
- Strong knowledge of CTD/ACTD dossier preparation, FDA/DCGI regulations, and international regulatory submissions.
- Excellent coordination, documentation, and communication skills.
Apply Now - 9377165778
Pay: ₹1,000,000.00 - ₹1,200,000.00 per year
Work Location: In person
