Job for M.Pharm, B.Pharm in Regulatory Affairs at SeQuent Scientific

Alivira, a subsidiary of SeQuent Scientific, is a USD 150mn integrated global animal health company operating in the area of animal health with a strong presence across EU, Latin America, Turkey, Africa, India and CIS. Our operations are underpinned by comprehensive manufacturing capabilities, strict adherence to quality and compliance. We are headquartered in Mumbai with manufacturing facilities based in India, Turkey, Brazil and Spain with approvals from global regulatory bodies, including USFDA, EUGMP, WHO and TGA, among others.

Post : Regulatory Affairs

Role Summary/Purpose:
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 of 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.
- To prepare responses for queries received from Health authorities.
- Co-ordination with CMO’s.

Candidate Profile
- B. Pharm with 4 + 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.
- Good communication skills
- Effective coordination skills
- Proficient in MS Office and Excel

Additional Information
Experience : 1-3 years
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Ankleshwar
Industry Type : Pharma
End Date : 30th May, 2019