Organization : Alivira Animal Health Ltd
Department : Regulatory Affairs
Location : Thane
Experience : 3-5 years
Qualification : B.Pharm/M.Pharm
Job Description
Summary
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 swapnil.sarvankar@sequent.in