Vikram Soundale
Regulatory Affairs Manager @阿斯利康
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WORK HISTORY
Regulatory Affairs Manager @阿斯利康
EDUCATION
KINGSTON UNIVERSITY, LONDON
Masters, Pharmaceutical Sciences
Pune University
Bachelor, Pharmacy
MSBTE
Diploma, Pharmacy
SKILLS
ABOUT VIKRAM SOUNDALE
Global Regulatory Development- Project Manager Post approval- MAA, variations and labellingGlobal Regulatory Affairs- EMEA, APAC, LATAM and NACTA applications, Budget development, Strategic Clinical regulatory project Bidding.Phase I to IV studies in Oncology, CNS, Respiratory and Paediatrics on biologicals, biosimilars and NCE\'s.Orphan drug aplication, PIP, VHP guidelines Regulatory authority notifications, substantial amendments and GNA (query) handling- MHRA, IMB
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