Key Responsibilities

• Manage regulatory affairs activities for veterinary pharmaceutical products.

• Prepare, review, and submit product registration dossiers to regulatory authorities.

• Coordinate with the CDSCO, State FDA, and other regulatory authorities for approvals and licensing.

• Ensure compliance with Drugs and Cosmetics Act & Rules, Schedule M, GMP, and other applicable regulations.

• Prepare and maintain regulatory documentation, technical files, and product dossiers.

• Handle applications for manufacturing licenses, product permissions, and renewals.

• Coordinate with QA, QC, Production, R&D;, and Marketing departments for regulatory compliance.

• Review product labels, package inserts, and artwork to ensure regulatory compliance.

• Respond to regulatory queries and deficiency letters from authorities.





• Monitor changes in regulatory guidelines and implement necessary updates.

• Support internal, customer, and regulatory audits.

• Maintain regulatory records and ensure timely submission of required documents.

• Assist in launching current veterinary pharmaceutical products by obtaining regulatory approvals
Experience

8 - 12 Years
No. of Openings

3
Education

Graduate (B.Pharma, B.Sc)
Role

Regulatory Affairs Manager
Industry Type

Pharma / BioTech / Clinical Research
Gender

[ Male / Female ]
Age Limit

22 - 40 Yrs.
Job Country

India
Type of Job

Full Time
Work Location Type

Work from Office

📌 Regulatory Affairs Manager Veterinary Pharmaceuticals Vile Parle East
🏢 Double Hr Consultancy
📍 Vile Parle East