CMC Rx Workstream lead for top MNC client. Managing a team of 30+ folks supporting end to end post approval submissions for pharma CMC portfolio as per committed timeline ensuring high quality submission. Key responsibilities are Oversight on business critical projects, complex submissions QC, leadership and operational activities, Resourcing, Risk Management and Issue management.Workstream Lead for Medical Device group in addition to CMC workstream responsibility and having 4 members team supporting Medical device clients for MDD to MDR conversion, MDR CE mark file creation, 510 k submission and WHO submission. Key responsibility are resourcing for the group and ensure adequate support to other projects on need basis, knowledge sharing, thought capital development in order to explore untapped opportunities.Expertise in medicinals (including various dosage forms including Oral solid, parentrals, Opthalmics, creams, gel, Solutions, powder, ointments and suppositories) and medical devices (expertise in MDR implementation). A great Project Manager and had led various company wide projects for Regulatory function.Majority experience working on Pharmaceutical, OTC, Medical Devices, Radio pharmaceuticals and food supplements. Handsome knowledge of biologicals and naturals. Markets worked upon are Europe, US, CIS, GNE, Asian markets together with other rest of the world markets.Have sound knowledge of product life cycle management activities for medicinal and Medical Devices. Handsome knowledge of CMC activities for initial submission. Expertise in EU variations, conversion of NTA to CTD, Annual reports, site transfer projects, Analytical methods update, MDR, DMF and ASMF update.