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Job #02972

About our client Our client is an emerging biopharmaceutical company that is focused on the development and commercialization of next generation therapeutics for infectious diseases and cancer. With an experienced CEO and a strong, diverse pipeline, they present a great opportunity for the right candidate! Position Location Senior Director of Global Regulatory Affairs Vermont, New Jersey, New Hampshire, New York, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Handle regulatory activities through all phases of drug development 2) Develop/implement strategies for earliest possible approvals of phase 1 – 4 applications 3) Direct and manage the Regulatory Team 4) Lead cross-functional teams in preparing regulatory submissions 5) Provide expertise in translating regulatory requirements into workable plans 6) Coordinate meetings with regulatory authorities 7) Provide regulatory support to ensure worldwide trial implementation 8) Maintain familiarity with regulations/guidelines governing drug development and approval (globally) Requirements 1) Advanced degree in a scientific discipline 2) 5+ years of experience in working in the Regulatory Affairs Department of a drug development company 3) Familiarity with managing staff in foreign offices, particularly India 4) Experience in preparing major regulatory submissions 5) Superb communication, collaboration and leadership skills 6) Motivated and flexible individual