Regulatory Affairs Manager (Veterinary Pharmaceuticals)

Double HR Consultancy; Mumbai; On-site; INR 3,000,000 - 4,200,000; Full time

Job summary

Double HR Consultancy is seeking an experienced Regulatory Affairs Manager to oversee regulatory activities for veterinary pharmaceutical products in India. You will prepare, review, and submit dossiers, coordinating with CDSCO, State FDA, and other authorities to secure approvals and licenses.

You will ensure compliance with the Drugs and Cosmetics Act, Schedule M, GMP, and related regulations, while aligning QA/QC, Production, R&D, and Marketing teams.

Qualifications

• 8-12 years of regulatory affairs experience in pharma/biotech
• Graduate degree in pharmacy or science (B.Pharma/B.Sc) required
• Experience managing regulatory dossiers and approvals for veterinary products

Responsibilities

• Prepare, review, and submit registration dossiers to regulatory authorities
• Coordinate with CDSCO, State FDA and other authorities for approvals
• Ensure compliance with Drugs and Cosmetics Act, Schedule M, GMP
• Prepare regulatory documentation, technical files, product dossiers
• Handle licenses, product permissions, and renewals
• Review labels, inserts and artwork for regulatory compliance
• Assist in audits and regulatory queries
• Support launches of veterinary products with approvals

Skills

Regulatory Affairs

GMP Compliance

Documentation

Label Review

Education

B.Pharma / B.Sc

Job description

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