Senior Regulatory Affairs Executive

5 days ago

Mumbai, Maharashtra, India CareerFit Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Designation: Senior Executive Regulatory Affairs & QA

Job Profile:

  • Responsible for registration of Pharmaceutical, Nutraceutical, Cosmetic products especially in international markets like ROW, MENA, SEA, LATAM etc.
  • Compile, Review & Submit the Dossiers to the Distributors as per the MOH guidelines.
  • Coordinating & follow-up up with the suppliers and distributors regulatory team for document review, compilation & submission to the necessary authority.
  • Preparation, collation & review of the registration documents pertaining to product registrations along with query resolution.
  • Follow up and coordinate with various departments across the company to collate documents required for regulatory submissions on time.
  • Preparing and maintaining a regulatory budget sheet, product registration records.
  • Draft policies and SOPs for the company from a Quality perspective.
  • Prepare and approve labelling & artwork as per specific country requirements for domestic and export markets.

Education & Experience:

  • Bachelors in B. Pharm (preferred) or any other science graduate.
  • Minimum 4+ years experience in International Registration.
  • Immediate joining is preferred.
  • Excellent Written & Verbal English communication.
  • Self-starter & energetic.

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