Regulatory Affairs Officer

Job details

Qualifications & Experience:

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

 3–4 years of experience in pharmaceutical, veterinary, or nutraceutical regulatory

affairs

 Strong 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: ₹500,000.00 - ₹900,000.00 per year

Benefits:

Work Location: In person