• Preparation, review, and submission of regulatory dossiers (DMF, CEP, etc.)
• Handling regulatory queries and deficiency responses
• Compilation and review of technical documents in line with global requirements
• Coordination with cross-functional teams (R&D;, QA, QC, Production)
• Ensuring compliance with international regulatory guidelines
Preferred candidate profile
•M.Sc. Organic / Analytical Chemistry / M.Pharma
- 2 to 10 years of experience in API Industry
📌 Regulatory Affairs | API (Vadodara)
🏢 Ami Lifesciences
📍 Vadodara
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