Greg Dombal
Chief Operating Officer
Greg joined Halloran Consulting Group in 2007. He focuses on helping emerging companies navigate the challenges of product development while establishing appropriate clinical, regulatory, and compliance structures to drive efficient development. He specializes in working with companies facing challenging development situations that require direct and specific Regulatory decisions.
With Halloran, Greg represents clients in worldwide regulatory negotiations and routinely functions as an on-demand Head of Regulatory and/or Clinical Affairs.
Greg brings over 18 years of experience in worldwide regulatory affairs, quality assurance and clinical operations. Prior to joining Halloran, Greg was responsible for the regulatory affairs and quality assurance groups at ArQule. He also directed development operations for the oncology portfolio while managing the Company's key strategic alliances with Kyowa Hakko Kogyo and Roche.
Prior to joining ArQule, Greg managed a variety of regulatory affairs functions at PAREXEL International, Antigenics, Genzyme and DepoTech. He has successfully filed over 30 clinical trial applications (IND or equivalent) and obtained Orphan Drug designation and/or Fast Track designation for eight individual products. He has successfully negotiated multiple Special Protocol Agreements and has had extensive involvement with NDA/MAA submissions resulting in multiple product approvals.
Greg holds a B.S. in Biology from the University of North Carolina – Chapel Hill. He is also a certified change management professional from Colorado State University. He sits on the Board of Directors of the TriROK Foundation, a 501(c)(3) non-profit dedicated to eliminating childhood obesity.
Publications
Events