Associate Director , Regulatory Affairs

Laboratory Animal Management Association

Maharashtra, India
On-site
Product registration for indian market
Compliance to applicable laws and regulations
Development of dossiers for export and local market
The Laboratory Animal Management Association is seeking an Associate Director of Regulatory Affairs to ensure compliance with Indian regulations for product registration, develop export dossiers, and maintain relationships with regulatory authorities. The role demands significant experience in the veterinary market, including leadership, strategic initiatives, and cross-functional teamwork

Job Summary

  • Responsible for the registration of products for the Indian Market, ensuring compliance with all applicable laws and regulations for both own and contract manufacturing.
  • Key responsibilities include the registration of imported pharmaceuticals and vaccines, local biological & pharma products, and the development of dossiers for export markets.
  • The role requires maintaining licenses, ensuring regulatory compliance for clinical trials, coordinating toxicity studies, and managing archives while adhering to EHS, OHSAS, and ISO standards.

Matching Summary

Match Score: 85

The Laboratory Animal Management Association is seeking an Associate Director of Regulatory Affairs to ensure compliance with Indian regulations for product registration, develop export dossiers, and maintain relationships with regulatory authorities. The role demands significant experience in the veterinary market, including leadership, strategic initiatives, and cross-functional teamwork.

Skills & Requirements

Must-have

  • product registration for Indian market
  • compliance to applicable laws and regulations
  • development of dossiers for export and local market
  • liaise with concerned authorities
  • registration of imported pharmaceuticals and vaccines
  • registration of local biological & pharma products
  • renewal & maintenance of all licenses
  • regulatory compliance for clinical trials
  • initiation and co-ordination of Toxicity studies

Nice-to-have

  • strategic initiatives for new product developments
  • improving market share for company's business
  • build teamwork within the department
  • keeping the team motivated irrespective of regulatory hurdles

Key Requirements

  • 15 years relevant experience in the ethical veterinary market
  • BVSc & AH or other related Science qualification
  • PGDMM Desired
  • Technical Knowledge /Market Knowledge / Product Knowledge / Disease knowledge
  • Rapport with GOI authorities / Relationship with drug authorities
  • Rapport with MoA & IVRI, DAHDF
  • Rapport with International teams
  • Good communication skills in written and spoken English
  • Good networking skills
  • Ability to operate effectively across different cultural zones

Work Rights

Not specified

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