Associate Director , Regulatory Affairs

Merck & Co., Inc.

India
Not specified
Registration of imported pharmaceuticals and vaccines
Development of export dossiers for local products
Liaison with regulatory authorities and industry forums
Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs in India to oversee the registration of pharmaceutical products and ensure compliance with relevant regulations. The ideal candidate will have extensive experience in the veterinary market, strong communication skills, and the ability to lead a team while driving strategic initiatives

Job Summary

  • The role is responsible for the registration of imported pharmaceuticals and vaccines as well as local biological and pharma products for the Indian market.
  • Candidates must ensure full compliance with internal policies, GMP standards, and international regulations while developing complex dossiers for export markets.
  • The position involves leading a team to manage archives, coordinate toxicity studies, and maintain strategic relationships with government authorities and industry bodies.

Matching Summary

Match Score: 85

Merck & Co., Inc. is seeking an Associate Director of Regulatory Affairs in India to oversee the registration of pharmaceutical products and ensure compliance with relevant regulations. The ideal candidate will have extensive experience in the veterinary market, strong communication skills, and the ability to lead a team while driving strategic initiatives.

Skills & Requirements

Must-have

  • Registration of imported pharmaceuticals and vaccines
  • Development of export dossiers for local products
  • Liaison with regulatory authorities and industry forums
  • Compliance with GMP, ISO, and EHS standards
  • Supervision of subordinate staff and team leadership

Nice-to-have

  • Strategic gap analysis for new product development
  • Building rapport with KOLs and veterinary organizations
  • Experience with clinical trial regulatory compliance
  • Cross-cultural communication skills
  • Proactive networking with drug authorities

Key Requirements

  • BVSc & AH or related science qualification
  • 15 years relevant experience in ethical veterinary market
  • PGDMM desired
  • Technical knowledge of disease and product specifics
  • Strong rapport with GOI authorities and MoA/IVRI

Work Rights

Not specified

Tailored Resume

Cover Letter