Regulatory Compliance

Primary Job Function

To lead and manage all regulatory affairs activities at the manufacturing site located at Mumbai and LL locations, ensuring timely regulatory submissions, compliance with regulations, and providing strategic support to institutional and international business operations. The role is critical to maintaining business continuity and regulatory compliance.

Core Job Responsibilities

Regulatory Submissions and compliance

• Prepare and submit various applications such as additional product permission, Layout approval, facility modification approval, technical person approval, Test license, amendments in licenses, State GMP and GLP certificate applications, post approval changes etc. to State FDA
• Prepare and submit applications such as Test license NOC, WHO GMP applications, CPP applications for additional products.
• Ensure timely submissions and approvals for all regulatory filings.
• Evaluate technical and scientific data for regulatory submissions.
• Liaise with health authorities for inspections, clarifications, and approvals.
• Ensure compliance with D&C Act, NDPS Act, Gazette Notifications, and internal SOPs.

Product & Business Support

Documentation & Quality Oversight

Tender Certificates

Governance, SOPs & Training

Additional Responsibilities

Position Accountability / Scope

Minimum Education

B.Pharm / M.Pharm / M.Sc. or equivalent in pharmaceutical or life sciences discipline.

Minimum Experience / Training Required

Skills Required

Regulatory Submissions, Compliance, Regulatory Affairs, Quality Assurance