Executive – Regulatory Affairs

8 hours ago

Mumbai Metropolitan Region, India Lyka Labs Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Title:
Executive – Regulatory Affairs

Location: Grant Road, Mumbai

Reporting To: General Manager – Regulatory Affairs

Full-time, 5 Days working.

Position Summary:

We are seeking a detail-oriented professional to join our Regulatory Affairs team as an Executive. The role involves preparing, compiling, and submitting regulatory documents for product registration in
ROW
and Asian markets, including the Philippines, Kenya, Peru, and West African countries, while ensuring timely coordination with internal teams and regulatory authorities for compliant and accurate submissions.

Key Responsibilities:

  1. Prepare, compile, and submit regulatory dossiers as per country-specific requirements.
  2. Prepare documentation required for COPP and courier dispatch.
  3. Review product artworks and labeling to ensure compliance with regulatory guidelines.
  4. Coordinate legalization and notarization of documents as per regulatory requirements.
  5. Maintain and update regulatory database and documentation as per company procedures.
  6. Ensure timely submission of dossiers, product samples, and associated documentation to clients for onward submission to the respective FDA.
  7. Prepare and review documents related to audits.
  8. Draft and submit responses to queries from regulatory authorities, including preparation or justification letters.
  9. Coordinate with manufacturing plants for sample arrangements and ensure all documentation required for product registration is available and accurate.
  10. Collaborate closely with cross-functional teams including Production, Quality Assurance, and Quality Control to collect, compile, and organize data as per submission timelines.

Required Qualifications & Experience:

  • Educational Qualification: B.Pharm / M.Pharm
  • Experience: Minimum of 4-6 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs.

Skills & Competencies:

  • Strong understanding of international regulatory guidelines and dossier requirements.
  • Technical and scientific knowledge of pharmaceutical products.
  • Excellent organizational and documentation skills.
  • Good communication and interpersonal abilities.

How to Apply:

To apply, please send your most recent CV to

Kindly mention the position title
"Executive – Regulatory Affairs"
in the subject line of your email.

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