JOB DESCRIPTION

REGULATORY AFFAIRS EXECUTIVE FDA LIAISONING

Position: Regulatory Affairs Executive
Department: Regulatory Affairs
Number of Positions: 01
Location: Head Office
Reporting To: Head – Regulatory Affairs
Experience: Minimum 4 Years
Industry: Pharmaceutical – Finished Formulations

1. JOB PURPOSE

To support and manage regulatory activities related to pharmaceutical finished formulations, including preparation, submission, follow-up and maintenance of regulatory dossiers and effective liaisoning with FDA/Drug Regulatory Authorities, consultants, agents and internal departments for timely regulatory approvals and compliance.

2. KEY RESPONSIBILITIES

A. Regulatory Affairs – General
- Prepare, review, compile and maintain regulatory dossiers for pharmaceutical finished formulations.
- Coordinate preparation of regulatory submissions in accordance with applicable country-specific requirements.
- Review product information, formulations, specifications, manufacturing processes, packaging materials, artworks and supporting documents for regulatory compliance.




- Coordinate with QA, QC, Production, R&D;, Supply Chain and other departments for collection of regulatory documents.
- Maintain regulatory submission trackers, approval status, commitments and renewal calendars.
- Prepare responses to regulatory queries, deficiencies and clarification letters under the guidance of the Head – RA.
- Maintain proper regulatory records and submission archives.

B. FDA / Regulatory Authority Liaisoning
- Coordinate and liaise with FDA/State FDA/Drug Regulatory Authorities and other competent regulatory authorities, as applicable.
- Follow up on applications, licenses, registrations, variations, permissions, renewals, NOCs and other regulatory matters.
- Coordinate with regulatory consultants/agents and authorized representatives for regulatory submissions and follow-up.
- Prepare and coordinate responses to observations, queries and deficiencies received from regulatory aut

📌 Walk-in || Regulatory Affairs Executive (Navi Mumbai)
🏢 PSA Chemicals And Pharmaceuticals
📍 Navi Mumbai