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Job #03536

About our client Our client is an early stage pharmaceutical company headquartered in New York that is focused on the commercialization of next generation oncology therapies. They have a world class CEO, strong financing and a robust technology platform that has shown significant potency in the early stages of development. This is an excellent opportunity for a proven regulatory executive to put their drive and initiative to work. Position Location Director of Regulatory Affairs New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Will serve as the senior regulatory leader for the company and will provide regulatory oversight and guidance for programs in development. 2) Develop regulatory strategy and oversee effective implementation. 3) Provides guidance on FDA requirements regarding all aspects of product development and timing, logistics and operational recommendations. 4) Utilize technical knowledge and effectively apply regulations and guidelines to the product development process. 5) Develop regulatory submission strategies in agreement with product development objectives, and manage regulatory submission strategies. 6) Provide authoring, review, and coordination for submissions to regulatory agencies. 7) Serves as regulatory liaison to the FDA and other regulatory authorities for programs. Requirements 1) Advanced degree in life science field required. 2) Proven track record of experience leading Regulatory Affairs for early stage companies with multiple compounds in advanced development (IND to NDA). 3) Must have extensive expertise in oncology therapeutics. 4) In-depth knowledge of FDA and international regulations and guidelines. 5) Must be a dynamic leader with outstanding communication, strategic and collaboration skills.