Support Medical Affairs objectives for assigned Cardio-Diabetes / Specialty therapies in emerging markets. Provide scientific and clinical inputs using current guidelines, clinical data, and real-world evidence.
Contribute to preparation and delivery of regulatory submissions from a global and regional perspective. Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
Responsible for one or several of the following: processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information
MSc in life sciences and FOUR years experience in molecular and cellular biology lab OR MTech and TWO years experience OR PhD. CSIR-Centre for Cellular and Molecular Biology, Hyderabad
M.Sc. in Analytical Chemistry with 2-6 years of Analytical R&D experience, skilled in HPLC, GC, and wet chemistry. Experience in sample analysis and release; proficient in Empower. LC-MS exposure preferred. Open to shifts.
Masters degree (M.Sc/ M.Tech./M.E.) in Biotechnology, Biomedical Engineering, Life Sciences, Molecular Biology, Biochemistry, or related disciplines with experience in cell and tissue culture