A pharmaceutical development and regulatory expert with over 35 years of experience in oncology and cell therapies. Experience at multiple managerial levels within pharmaceutical companies and most recently as Senior Vice President for Quality, Regulatory and CMC, for IO Biotech Limited, gaining significant experience in co-ordinating, planning and running a global development of pharmaceutical biological product.My experience is wide ranging, allowing fast, effective development of medicinal products. Roles have included:• SVP Quality, Regulatory and CMC sitting on core C-suite providing CTO support activities – overseeing all pharmaceutical development of drug substance and drug products for peptide molecules and ensuring appropriate quality systems are in place. Management of CDMOs, CROs and distribution chains. In addition, oversight of all Regulatory activities and determination of CMC and clinical regulatory requirements in EU and US. Within this role multiple achievements were obtained including: -o Obtaining Breakthrough Designation status with CBER (Office of Tissues and Advanced Therapies Division).o Securing largest Series B in 2020 in cooperation with CEO and CMO.o Overseeing 5 FDA meetings with 9 months to expedite the development program from Phase 1 to Phase 3.o Implementation of an electronic QMS and Quality Docs systemo Oversight of all CMC activities, including drug substance synthesis, scale up and validation plans and complete drug product reformulation and scale and transfer to commercial siteso Oversight of all analytical activities and implementation of FDA agreed bioassau for potency together with orthogonal testing program.• Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintain patient focus.• Orphan drug registrations of vaccine products and synthetic molecules• NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised submission)• Support for NBE during clinical phases and CMC/ clinical Strategy and support for a Biosimilar• Oversight of Regulatory strategy for ATMP (Cancer vaccine) and CMC Strategic oversight for Phase 3 ATMP (Stem Cell Treatments)• Training to major pharmaceutical companies for Chemistry and Pharmacy section of the dossier and Life Cycle Management.