CEO & Chairman Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, announced today that Octagon has recruited two Regulatory professionals and a seasoned business development resource to support its European Operations.
Rohit Malhotra has been appointed to the position of director, Regulatory Affairs. Mr. Malhotra previously spent six years in Global Regulatory Affairs at Johnson & Johnson, most recently as a Global Dossier Leader. Prior to joining Johnson & Johnson he spent eight years at the Medicine Control Agency (MCA) where he held various positions within the Licensing Division. During his tenure at the MCA, Mr. Malhotra managed a team of life scientists responsible for conducting pre-assessment validation checks for all new Marketing Authorisation Applications (MAAs) submitted to the Agency
Amanda Keller has been appointed to the position of senior manager, Regulatory Operations. Ms. Keller joins Octagon from Merck & Co. Inc. (NYSE: MRK) where she held the position of Senior Regulatory Operations Specialist. In this role, Ms. Keller gained expertise in the concepts of global submission process management.
Finally, Samantha Weston joined the team as director, Business Development for European Operations. Ms. Weston brings expertise in the contract research business. As director of Business Development, Ms. Weston will be responsible for directing and managing the company’s business development activities, spearheading initiatives to expand Octagon’s European business and client base.
Mark Turner, managing director, European Operations, expressed his pleasure in being able to assemble such a strong team. “We are expanding our European capabilities by building a strong regulatory foundation and attracting talent that is unparalleled in industry. This expertise continues to differentiate our services and products and will be critical to success in the complex European market.”
Jim Walker, chairman and CEO of Octagon, added, “The high caliber of the European team will enable us to ramp up quickly and provide exceptional service to our valued European clients. Bringing such expertise in house continues our tradition of hiring top talent to address the evolving needs of the pharmaceutical and biotechnology industry."
About Octagon Research Solutions, Inc.
Octagon (octagonresearch.com) is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through deep domain knowledge, cross-functional electronic submission expertise, a holistic process approach, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Amersham, UK.