Associate Director , Regulatory Affairs

Merck & Co., Inc.

Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Liaison with government drug authorities in india
The role is responsible for the registration of products for the Indian market, ensuring full compliance with all applicable laws and regulations

Job Summary

  • The role is responsible for the registration of products for the Indian market, ensuring full compliance with all applicable laws and regulations.
  • Candidates must develop comprehensive dossiers for both local biological/pharmaceutical products and export markets while coordinating with international teams.
  • The position requires maintaining strong relationships with regulatory authorities such as MoA, IVRI, and DAHDF to secure necessary licenses and approvals.

Matching Summary

The role is responsible for the registration of products for the Indian market, ensuring full compliance with all applicable laws and regulations.

Skills & Requirements

Must-have

  • Registration of imported pharmaceuticals and vaccines
  • Development of regulatory dossiers for export markets
  • Liaison with government drug authorities in India
  • Management of GMP and manufacturing licenses
  • Coordination of toxicity studies and clinical trials

Nice-to-have

  • Strategic gap analysis for new product development
  • Building rapport with industry forums and KOLs
  • Leading and developing subordinate RA team members
  • Experience with ISO and EHS standards implementation

Key Requirements

  • BVSc & AH or related Science qualification
  • 15 years relevant experience in ethical veterinary market
  • PGDMM Desired
  • Technical knowledge of local and imported pharmaceutical products

Work Rights

Not specified

Tailored Resume

Cover Letter