Job Title: Regulatory Affairs Manager - Mumbai

We are seeking an experienced Regulatory Affairs Manager to manage all regulatory ac vi es 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.

Job Responsibility
- 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.Key Skills:Mandatory:
- Solid 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.
- Good understanding of QA, QC, Production, and Manufacturing processes.
- Strong communication, documentation, and analytical skills.
- Proficiency in Microsoft Office and regulatory do

📌 Regulatory Affairs Manager (Vile Parle)
🏢 Winways Chemtech
📍 Vile Parle