Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Liaison with government regulatory authorities
MOBS Lab is seeking an Associate Director of Regulatory Affairs responsible for ensuring compliance with laws and regulations related to the registration of pharmaceutical products, both imported and local, in India. The ideal candidate will have extensive experience in veterinary medicine and regulatory affairs, along with strong communication skills and the ability to lead a team
Job Summary
The role involves registering veterinary products, including pharmaceuticals and vaccines, for the Indian market while ensuring full compliance with local laws.
Candidates will lead strategic initiatives to improve market share by identifying opportunities through gap analysis and managing dossier development for export markets.
The position requires maintaining strong relationships with government authorities like MoA and IVRI to secure licenses and navigate regulatory hurdles effectively.
Matching Summary
Match Score: 85
MOBS Lab is seeking an Associate Director of Regulatory Affairs responsible for ensuring compliance with laws and regulations related to the registration of pharmaceutical products, both imported and local, in India. The ideal candidate will have extensive experience in veterinary medicine and regulatory affairs, along with strong communication skills and the ability to lead a team.
Skills & Requirements
Must-have
Registration of imported pharmaceuticals and vaccines
Development of regulatory dossiers for export markets
Liaison with government regulatory authorities
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
Cross-functional collaboration with marketing teams
Internal auditing of ISO and EHS standards
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