Avisek Mukhopadhyay

Working within 14 members of team to harmonize the regulatory activities for pharmaceutical drugs and combination products worldwide being an Innovator brand. • Proper guidance to product support team & technical writing of the registration dossier specially Module-2 (QOS) and Module-3 (CMC), complete review of the technical modules. • Representing Regulatory affairs team on behalf of team in management (Core & Cross functional) to produce the yearly growth.

• Writing of Module-1, 2 & 3 regulatory sections to get timely regulatory approval, Product Renewal, Life cycle management for pharmaceutical drugs in FDA, EMA, PMDA, and TGA. • Produce project reports at fixed intervals for senior management; identify key bottlenecks and potential pitfalls; proactively suggest measures to keep certification projects on schedule and under assigned budgets. To maintain a proper regulatory environment.

• Supported regulatory fillings & technical documents as per the eCTD requirement for EU, USA. Manage full spectrum of process covering new product registration, registration amendment and renewal registrations. • Develops & maintains regulatory standards and policies that impact potential issues related to the market. Works in collaboration with other Quality and Regulatory colleagues.

Pharmaceutical Chemistry