Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Compliance with gmp, iso, and ehs standards
The role is responsible for the registration of products for the Indian market, ensuring full compliance with applicable laws and internal policies
Job Summary
The role is responsible for the registration of products for the Indian market, ensuring full compliance with applicable laws and internal policies.
Candidates must lead the development of technical dossiers for local biological and pharmaceutical products intended for export markets while maintaining archives.
The position requires building strong rapport with regulatory authorities such as MoA and IVRI to secure licenses and navigate registration hurdles.
Matching Summary
The role is responsible for the registration of products for the Indian market, ensuring full compliance with applicable laws and internal policies.
Skills & Requirements
Must-have
Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Compliance with GMP, ISO, and EHS standards
Liaison with government regulatory authorities
Management of toxicity studies and clinical trials
Team leadership and subordinate supervision
Nice-to-have
Strategic gap analysis for new product development
Networking with industry forums and KOLs
Experience in ethical veterinary market
Cross-cultural communication skills
Internal audit capabilities
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