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