Job Description:
We are looking for a motivated and detail-oriented Drug Regulatory Affairs Executive to join our Regulatory Affairs team. The candidate will be responsible for preparation, review, compilation, and submission of regulatory documents/dossiers for pharmaceutical products in regulated and semi-regulated markets.
Roles & Responsibilities:
* Preparation and compilation of CTD/ACTD dossiers.
* Review of regulatory documents including COA, specifications, artworks, PIL, labels, and packaging materials.
* Coordination with internal departments for collection of required documents and data.
* Handling product registration activities and regulatory query responses from clients/health authorities.
* Preparation and review of Module 1 to Module 5 documents as per regulatory requirements.
* Maintaining submission trackers and regulatory databases.
* Coordination with third-party vendors/consultants for regulatory documentation support.
* Ensuring compliance with applicable regulatory guidelines and company standards.
* Must have worked with the pharma Company before and must be from the B.Pharma / M.Pharma Background.
Pay: ₹45,000.00 - ₹50,000.00 per month
Work Location: On the road
