Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Management of gmp and manufacturing licenses
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 lead the development of dossiers for both local biological and pharmaceutical products intended for export markets while maintaining archives and ISO standards.
This position requires building strong relationships with government authorities such as MoA and IVRI to facilitate license approvals and renewals.
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
Management of GMP and manufacturing licenses
Coordination with regulatory authorities in India
Leadership of Regulatory Affairs team members
Nice-to-have
Strategic gap analysis for new product development
Building rapport with industry forums and KOLs
Experience with international packaging requirements
Ability to work across different cultural zones
Motivational leadership during regulatory hurdles
Key Requirements
BVSc & AH or related Science qualification
15 years relevant experience in ethical veterinary market
PGDMM desired but not mandatory
Technical knowledge of disease and product specifics