– Regulatory Manager (Veterinary Pharmaceuticals)

Job Summary

We are seeking an experienced Regulatory Affairs Manager to manage all regulatory activities related to veterinary pharmaceutical products. The candidate will be responsible for product registrations, dossier preparation, regulatory submissions, license management, and ensuring compliance with all applicable veterinary pharmaceutical regulations.

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.

Qualification

- B.Pharm / M.Pharm / M.V.Sc. / M.Sc. or an equivalent qualification.
- Additional certification in Regulatory Affairs will be an added advantage.

Experience

- 8–12 years of experience in Regulatory Affairs within the veterinary or pharmaceutical industry.
- Experience in handling product registrations and regulatory approvals.

Required Skills

- Strong knowledge of Veterinary Pharmaceutical Regulations.
- Experience in CDSCO, State FDA, and product registration processes.
- Knowledge of Drugs and Cosmetics Act & Rules, Schedule M, and GMP.
- Expertise in dossier preparation and regulatory documentation.
- Valuable understanding of QA, QC, Production, and Manufacturing processes.
- Strong communication, documentation, and analytical skills.
- Proficiency in Microsoft Office and regulatory documentation systems.

Preferred Candidate Profile

- Experience in handling veterinary formulations, including injectables, oral liquids, powders, boluses, feed supplements, and topical products.
- Experience with domestic and international product registrations is preferred.
- Ability to coordinate effectively with cross-functional teams and regulatory authorities.

Pay: ₹800,000.00 - ₹1,000,000.00 per year

Benefits

- Health insurance
- Provident Fund

Work Location: In person

📌 Regulatory Manager (Andheri)
🏢 Artevet Therapeutic's
📍 Andheri