Priya Jambhekar

Biography

Priya Jambhekar is a consultant in regulatory and quality affairs with over thirty years of experience in the areas of product development, product safety, quality assurance, quality compliance, clinical operations, supply chain management and US and international regulatory affairs. She has extensive experience in establishing regulatory strategy for Chemistry, Manufacturing Controls, Clinical and Nonclinical development for 1st in the class products and operational excellence for optimal success during all aspects of pre- and post- approval phases of new drugs, devices, biologics, gene and cell therapy development and marketing of products covering various therapeutic areas, including metabolism and endocrinology, analgesic, anti-inflammatory, cardio-renal, pulmonary, oncology, gastrointestinal, dermatology, neurology, ophthalmology, urology, pain, anesthesia and addiction, vaccine products. Priya also has significant experience in the generic industry and have successfully defended ANDA applications with Paragraph IV certifications.

Strategies instituted by Priya have led to company getting a 6-month generic market exclusivity for block buster drugs and have maintained 2 player market for extended period of time, pediatric and orphan drug exclusivities. Priya also has extensive experience in handling of controlled substances, DEA and PDMA registrations, post market safety and medical communication and Health Care Compliance. Proven experience in handling FDA pre-approval inspections and product plant compliance. She has managed over 350 NDA / IND / ANDA / PMA / 510(k) projects in various stages of development for registration around the globe (US, EU, Japan, Canada, Asia, Australia, South and Latin America).

Priya has held positions such as Global Sr. VP of Regulatory & Quality at Paramount BioSciences, Global VP at Ethicon, a J&J company and Alkermes. Some of the other positions include Baxter ACC as regulatory head and Bristol-Myers Squibb. Priya was a part of the management team at Cardiovations & GyneCare, J&J companies and Alkermes. Currently, Priya is a part of the management team of several companies advising them on regulatory, quality, supply chain matters and clinical operation. Priya is a President and CEO of PBS Regulatory Consulting Group which she founded in 2008. 

Priya holds a M.Sc. in Organic & Biochemistry and M.S. in Pharmacy. She is also certified by Regulatory Affairs Professional Society and NJ Pharmaceutical Quality Control and Assurance Society.