Job for B.Pharm, M.Pharm in Regulatory Affairs at Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.

Looking for candidates with relevant experience in Regulatory Affairs

Post : Sr. Manager / Manager - Strategic International Expansion – RA

Department : Strategic International Expansion – RA
Post : Sr. Manager/ Manager
Location : Ahmadabad
Qualification : M.Pharma / B.Pharma
Experience : 12-15 Yrs. Emerging market (Preferable to have US submission knowledge)
Required skills
• Product specific evaluation and finalization of feasibility & suitability of products which are leveraging to emerging / international markets (MENA & China).
• Actively support HOD for design and decide product filing strategy for international market.
• Communicate and co-ordinate with Project Management and Business team for product execution.
• Flawless execution define filing strategy into different phases of international market submission.
• Finalize specific template of product Kick off form and due-diligence report for various international market based on their technical and administrative requirements.
• Review of registration dossier and end to end communication with various international business partners.