Job Description - Manager Regulatory

AffairsDepartment: Regulatory Affairs
Reporting To: Head Medical Services
Location:Mumbai
Industry: Pharmaceutical / Animal Health / Healthcare

Job SummaryThe Regulatory Affairs Manager is responsible for obtaining and maintaining regulatory approvals, licenses, registrations, and statutory compliance for pharmaceutical products. The role involves preparation and submission of regulatory dossiers, coordination with regulatory authorities, preparation, review and approval of product artworks, support for product registrations, import/export regulatory activities, and cross-functional collaboration with manufacturing, R&D;, business, and distribution teams.

Key Responsibilities

Regulatory Licensing & Approvals
- Coordinate with State FDA, CDSCO, and other regulatory authorities for obtaining approvals, licenses and license renewals

Regulatory Submissions & Documentation
- Prepare, compile, review, and maintain regulatory dossiers and supporting documents for submissions
- Prepare documentation for FDA submissions and regulatory inspections




- Maintain regulatory records, approvals, licenses, and correspondence

Artwork Review & Label Compliance
- Review and approve product artworks for in-house manufacturing, third-party manufacturing, and tender business
- Ensure compliance of labels, cartons, inserts, and packaging materials with applicable regulatory requirements
- Prepare and verify product content, claims, prescribing information, and statutory declarations

Portal Management & Regulatory Databases
- Update and maintain regulatory information on CDMS and other government portals
- Support registrations and renewals through various regulatory portals, including ONDLS and other applicable platforms
- Ensure timely submission and updating of regulatory information.

Regulatory Coordination
- Coordinate with Manufacturing, Quality Assurance, Quality Control, R&D;, Supply Chain, and Business teams for regulatory compliance
- Liai

📌 Manager - Regulatory Affairs (Mumbai)
🏢 Samarth Life Sciences
📍 Mumbai