Regulatory Affairs Specialist

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 :