Jagdishwar Patel

About Jagdishwar Patel

Experienced Regulatory Affairs (RA) – CMC (Chemistry, Manufacturing & Controls) leader with over 27 years of combined experience in developing and executing Global RA CMC strategies and leading CMC projects as related to drug product life-cycle management at FDA, pharmaceutical, and biotechnology industries. RA-CMC experience accounts for leading interdisciplinary teams and managing the interplay between Health Authorities (US, Canada, Europe, China and Japan) for regulatory CMC submissions (small molecules and biologics) that include INDs/IMPDs, NDAs/BLAs/MAAs, PAS, CBEs, Amendments, CTAs, CTNs, Supplements/Variations, Annual Reports, IB’s/DSURs (CMC) and the organizations based on strategic science and risk based (ICH Q9) regulatory review strategies. CMC experience encompasses leading, planning and coordinating the portfolio of drug product development projects across various modalities (small and large molecules, and drug device combination products such as Inhalers and nasal products) at all clinical stages i.e, Phase I, II, & Proven ability to manage budgets and timelines through effective people, business, and resource management skills. A recognized CMC expert serving as primary group/project leader responsible for the development of CMC regulatory strategies, submissions and compliance activities.

Experience

1. Global Regulatory Affairs Cmc

   Incyte

   Jul 2021 — Present · Wilmington, DE, US

   RA-CMC Global lead for both small molecules (NCEs in Oncology/IAI/Dermatology) and biologics (monoclonal/bispecific antibodies) that involved planning, authoring, reviewing and approving CMC regulatory submission content and delivering successful CMC regulatory strategies for submission of IND/IMPD/NDA/MAA/CTA/CTA-Ns, Annual reports, Supplements/Variations and Amendments to FDA/EMA/HHS Canada/Japan PMDA Led cross-functional teams including technical operations, delivered overarching global CMC regulatory strategies for filing regulatory submission packages to different health authorities. Led authoring of CMC responses to several Information requests, provided guidance to technical operations on regulatory procedures, guidance and policies and successfully formulated CMC responses through proactive risk management and mitigation of potential regulatory issues.

Education

• Kakatiya University

  Bachelor of Science (B.S.), Pharmacy

• North Dakota State University

  Master of Science (M.S.), Pharmaceutical Sciences

• University of Rhode Island

  Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences