Sonika Shah
Regulatory Affairs Head
Amgen
Dynasty Business Park, A Wing, Level 4, Andheri Kurla Rd, Maharashtra, 400059
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.
