Regulatory Affairs Specialist

OR

Regulatory Compliance Specialist
Product Registration Executive
Regulatory Documentation Officer
Regulatory Analyst
Regulatory Affairs Coordinator

Last updated on 03 Dec 2025

Overview

A Regulatory Affairs Specialist plays a key role in preparing and submitting documents to regulatory authorities, ensuring that all company products meet local and international compliance standards. They work closely with R&D, QA, and legal teams to support product approvals and lifecycle management.

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Job Description
  1. Prepare, review, and submit regulatory filings such as DMFs, CTDs, and product dossiers.
  2. Track regulatory changes and advise internal teams on updated requirements.
  3. Communicate with regulatory authorities to address queries, deficiencies, and follow-ups.
  4. Maintain detailed records of approvals, licenses, and correspondence for audits.
  5. Support product labeling, packaging, and documentation review for compliance.
  6. Assist in the development of regulatory strategies during new product launches or modifications.
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Recruiter Hiring For this Job Role
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Gowrie Research Private Limited

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