Regulatory Affairs Associate
4 days ago
Roles and Responsibilities
- Prepare dossiers, variations, renewals, and amendments for USFDA regulatory submissions.
- Coordinate with third-party agencies for audits and inspections (USFDA, WHO).
- Ensure compliance with GMP requirements through self-inspection and third-party audits.
- Maintain liaison with government authorities for licensing and approvals.
- Provide guidance on legal metrology regulations to ensure accurate product labeling.
Desired Candidate Profile
- 7-12 years of experience in Regulatory Affairs or related field (nutraceutical industry).
- Bachelor's degree in Pharmacy (B.Pharma) from a recognized institution.
- Strong knowledge of FSMS, Food Safety, HACCP, FSSAI, Legal Metrology, and GMP regulations.
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