Regulatory Affairs Manager (Veterinary Pharmaceuticals)

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 new 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