Mr. Dhariwal is a PMI-certified Program Management Professional (PMP®) expert in regulatory affairs with more than nine years of experience developing products from early stage to licensure worldwide. As a regulatory affairs professional, he advises on FDA/ICH requirements for nonclinical testing, GMP requirements for Chemistry, Manufacturing and Controls (CMC), and compliance requirements across different clinical stages of development. He has concurrently assisted the advancement of public health, infectious disease, rare disease, generic drug products, and medical devices in early development through commercialization.
Mr. Dhariwal is experienced in the cross-functional and robust preparation of pre- and post-approval regulatory submissions based on scientific merit with a strong understanding of the biotechnology/pharmaceutical development process. He has managed INTERACT, pre-IND, IND, BLA, MAA, designation requests, Q-Subs, and 510(k) submissions with the FDA. He is also a trained publisher to support global electronic submissions.
In addition, Mr. Dhariwal has supported government-funded projects (BARDA, DARPA, and NIAID), providing proposal writing, proposal manager, and post-award project management support. He recently managed a government-funded $12 million IVD COVID-19 diagnostics project, overseeing process validation, clinical validation, and regulatory submissions.
Mr. Dhariwal started his journey with quality assurance, managing audits and inspections, vendor management, overseeing documentation and training systems, and batch release and disposition. Prior to joining LBG, he worked at Alexion Pharmaceuticals, Genzyme, and Panacea Pharmaceutical.
Mr. Dhariwal has an educational background in pharmacy and holds an M.S. in Regulatory Affairs in Drugs, Biologics, and Medical Devices from Northeastern University in Boston.
