Teams at Biogen

Lead Biogen India's regulatory strategy and interactions with CDSCO/DCGI; drive submissions, lifecycle management, clinical trial and rare-disease regulatory strategies; oversee compliance, promotional review, regulatory intelligence, and cross-functional stakeholder engagement to support development and commercialization.

Lead establishment and oversight of local pharmacovigilance (PV) operations in India, ensuring regulatory compliance, ICSR handling, aggregate reporting, vendor management, PSMF maintenance, inspection readiness, training delivery, and contribution to global/regional PV strategy. Act as primary PV contact, manage audits/inspections, author local PV documentation, and support quality and distribution readiness tasks as required.