Associate Director , Regulatory Affairs

medhunter.de

Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Maintenance of gmp and manufacturing licenses
The role is responsible for the registration of products for the Indian market, ensuring compliance with all applicable laws and regulations

Job Summary

  • The role is responsible for the registration of products for the Indian market, ensuring compliance with all applicable laws and regulations.
  • Candidates must lead the development of dossiers for both local biological/pharmaceutical products and export markets while maintaining archives.
  • The position requires building strong relationships with government authorities such as MoA, IVRI, and DAHDF to secure necessary licenses.

Matching Summary

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

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

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter