Qualifications & Experience:

· M.Sc / B.Sc / M.Pharm / B.Pharm / Diploma in Regulatory Affairs

· experience in pharmaceutical, veterinary, or nutraceutical regulatory affairs

· Solid knowledge of global dossier preparation for veterinary drugs and feed supplements

Key Responsibilities:

· Ensure regulatory compliance with drug laws and feed supplement regulations

· Prepare and submit CTD / eCTD dossiers for regulated markets (USA, EU, Australia)

· Compile country-specific dossiers (CTD / ACTD formats)

· Liaise with regulatory authorities (FDA, DCI, State & Central bodies)

· Handle FSCs, legal documents, statutory compliance, and embassy-related documentation

· Manage FDA portal submissions, audits, and regulatory queries

· Review technical documents (validation, stability reports)

· Coordinate with plant, clients, and internal teams for documentation

· Review and approve product artworks as per regulatory guidelines

Pay: ₹800,000.00 - ₹1,400,000.00 per year

Benefits

- Health insurance
- Life insurance
- Provident Fund

Work Location: In person

📌 Regulatory Affairs Officer (Mumbai)
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