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