Role: Regulatory Affairs

Organization : Alivira Animal Health Ltd

Department : Regulatory Affairs

Location : Thane

Experience : 3-5 years

Qualification : B.Pharm/M.Pharm

Job Description

To ensure the timely submission of Dossiers, Query responses, Renewals in emerging markets, Variations/post approval changes and other day to day regulatory functions for Global regulatory filings

Key Responsibilities
  • Review data received from R&D, manufacturing and analytical departments for API and Formulation
  • Administration of registered projects in emerging markets
  • Co-ordination and administration of re-registrations
  • Compilation of dossiers for submission to emerging markets and regulated market
  • Co-ordination with cross –functional departments for collating of documents to ensure timely submission of dossiers
  • Provide inputs for support required by Business Development team
  • Prepare responses for queries received from Health authorities
  • Co-ordination with CMO’s

Qualifications and Experience required
  • B. Pharm with 3-5 years of experience in Drugs Regulatory Affairs (Formulation) with Pharmaceutical Industry
  • Hands on experience in handling dossier filings in emerging markets
  • Experience in regulated market would be an added advantage

If this vacancy interests you, please send your resume to