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Job #03622

About our client Our client is a leading regulatory consulting services firm that enables emerging biotechnology, pharmaceutical and medical device companies to expedite the process of bringing innovative products to market. The company has offices around the globe and a proven management team with previous tenures at a number of industry leading organizations and various divisions of key regulatory agencies. This is a strong opportunity for someone that wants to put their drive and initiative to work in an entrepreneurial environment. Position Location Regulatory Project Director, Drugs and Biologics Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Work in an international environment 2) Supervise several projects and manage teams of regulatory consultants 3) Design and implement innovative product development strategies 4) Handle regulatory agency interactions and prepare regulatory submissions 5) Communicate and meet regulatory agencies 6) Handle validation of regulatory submissions 7) Interact with clients and team management Requirements 1) MS or equivalent 2) Minimum 5 – 7 years of international regulatory experience 3) Experience in biologics 4) Successful staff management experience (not just supervisory but direct) 5) Experience in biotechnology products is valuable as is experience with non-clinical and clinical development 6) Recent interaction with the FDA related to approval of biotechnology products