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
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.
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
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