Darshan Patel Email & Phone Number

EXECUTIVE PROFILEHigh-performing individual with global regulatory expertise providing leadership and strategic support to cross-functional teams across the product life-cycle in central nervous system (CNS), oncology, cardiovascular and hematology therapy areas. Proven ability to develop and implement robust regulatory strategies to achieve drug development and business goals. Demonstrated experience in leading negotiations with global health authorities. Possess excellent interpersonal skills and the ability to communicate effectively with medical and scientific staff at all levels.KEY ACCOMPLISHMENTS•Developed and executed comprehensive regulatory strategy through cross-functional collaboration delivering first cycle approvals for NDA (FDA), MAA (EMA, SwissMedic and MHRA) and NDS (Health Canada) for company's first asset, accelerating market access and generating significant revenue.•Built and developed high-performing global regulatory affairs team consistently exceeding expectations on critical KPIs. •Oversaw the compilation, submission and successful activation of over 10 INDs.•Led significant contribution to first cycle approvals of efficacy supplements for addition of new indications.•Maximized global study start-up operations by redefining the regulatory strategy for submissions of clinical trial applications (CTA).•Expertise in negotiating with global health authorities and reversing negative opinions on company CTAs.•Delivered first cycle approvals of various chemistry, manufacturing and controls (CMC) and labeling supplements. •Conceptualized and implemented medical information and drug safety departments resulting in 50% reduction in outsourcing costs, achieving a 100% compliance rate for global reporting of serious adverse events and improving the overall quality and consistency of individual safety reports.

Listed skills include Regulatory Affairs, Clinical Development, Pharmaceutical Industry, Drug Development, and 13 others.