Medical Writing jobs in Delhi, Delhi

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