Associate Director , Regulatory Affairs

Merck & Co., Inc.

Not specified; not specified; not specified
Not specified
Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Maintenance of gmp and manufacturing licenses
Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs responsible for managing the registration of pharmaceutical and biological products in the Indian market. The role emphasizes compliance with regulations, dossier development, and collaboration with regulatory authorities and cross-functional teams

Job Summary

  • The role involves registering veterinary products, including biologicals and vaccines, for the Indian market while ensuring full compliance with local laws.
  • Candidates will lead the development of complex regulatory dossiers for both local and export markets, coordinating with global teams and laboratories.
  • This position requires strategic leadership to manage a team, maintain archives, and build strong relationships with government authorities and industry organizations.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs responsible for managing the registration of pharmaceutical and biological products in the Indian market. The role emphasizes compliance with regulations, dossier development, and collaboration with regulatory authorities and cross-functional teams.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Registration of imported pharmaceuticals and vaccines
  • Development of regulatory dossiers for export markets
  • Maintenance of GMP and manufacturing licenses
  • Coordination with regulatory authorities in India
  • Leadership of Regulatory Affairs team

Nice-to-have

  • Strategic gap analysis for new product development
  • Building rapport with industry forums and KOLs
  • Experience with international packaging requirements
  • Ability to operate across different cultural zones
  • Motivating teams through regulatory hurdles

Key Requirements

  • BVSc & AH or related science qualification
  • 15 years relevant experience in ethical veterinary market
  • PGDMM desired
  • Technical knowledge of disease and product regulations

Work Rights

Not specified

Tailored Resume

Cover Letter