Sonika Shah – Regulatory Affairs Head

Sonika Shah

Regulatory Affairs Head

Amgen

Dynasty Business Park, A Wing, Level 4, Andheri Kurla Rd, Maharashtra, 400059

http://www.amgen.com/

Experience in handling new drug product registration for biological product and new chemical entities, subsequent new drug applications, lifecycle management of drug products, post approval variation,/ maintenance activities and regulatory approval/activities on clinical trial (Phase 2,3 & 4), Regulatory Compliance, Regulatory Intelligence Project Management, Training and Regulatory systems development.