Ishwari Kavdikar
Senior Director @Johnson & Johnson
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WORK HISTORY
Senior Director @Johnson & Johnson
High Wycombe, GB
I have had oversight and leadership of up to 25 professionals for a portfolio of Infectious Diseases and vaccines products which required strategic regulatory input to Clinical development for all products in all phases of development. I attended/ led F2F meetings with EMA & regional regulators for scientific advice procedures; PRIME, ILAP, MAA pre-submission, Co/Rapporteur meetings & Oral Explanations for standard, “conditional” and “Exceptional Circumstances” licences. I provided input & attended WHO meetings to discuss the “Regulatory Roadmap” prior to EUL, PQ as well as SAGE for both Ebola and Covid-19 vaccines.I led discussions with EMA on use of “QR” code and design of associated website for covid-19 vaccine. This required defining internal compliance & external legal parameters required to meet EMA’s requirements. Tasks included, Project Management of website implementation across EMEA region in operating companies working together with regulatory, IT and medical affairs.Prior to being EMEA RA Head of Infectious Diseases & Vaccines, as a special assignment, I established regulatory affairs as a core function in EMEA Emerging Mkts to support the commercial business & got leadership alignment to create a new specialist role “Emerging Markets Regulatory Liaison”. I also recruited regulatory affairs managers in Ghana and Kenya and met with regulators in Ghana and Kenya to build rapport.My first role at J&J was Director in the Haematology/Oncology team where I worked with Mkt Access, Med Affairs and Commercial teams to ensure Type II variations supported value proposition leading to significant commercial opportunity e.g, VELCADE: new indications - combination therapy, relapsed refractory myeloma, induction therapy; EPREX (epoetin alfa): New indication - Low risk MDS, safety (PRCA). I also led the first “Article 20” imposed by EC for a critical medicine in oncology supportive care (CAELYX)
EDUCATION
King's College London
BSc
UCL
MSc
ABOUT ISHWARI KAVDIKAR
I am a highly experienced & motivated regulatory affairs professional with over 20 years of experience of drug registrations/ life cycle management across Infectious Diseases, Vaccines, & Global Public Health, Emerging Mkts & oncology. Extensive line management experience leading a team of up to 25 professionals which focused on EU/EMEA regulatory procedures -CHMP & National ScAdvice; CTA & GMO applications; PIPs, MAA preparation; Co/Rapporteur meetings, liaison & participation in Regulatory inspections (GCP/GMP/PV), with inspectorate teams from national agencies & EMA, post marketing obligations (Conditional Marketing Authorization, “Exceptional Circumstances”); Oral Explanations, PRIME, ILAP, WHO PQ etc). My role required regulatory input to senior levels within the organization on all aspects of drug development including late life cycle regulatory strategy to maximize market access value. I also put forward a model for regulatory affairs as a core function in EMEA Emerging Mkts and the creation of a new specialist regional role “Emerging Markets Regulatory Liaison” to enable commercial success in the region.
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