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Job #03380

About our client Our client has an established presence in all global AIDS crisis zones including East and South Africa. They also recently opened a 36,000 square foot state-of-the-art lab in New York. Exceptional management team and board, the Vice President of Vaccine Development is former Global Vice President of Process Development at Sanofi Pasteur, the largest vaccine company worldwide.World class corporate (i.e. Pfizer, Bristol-Meyers, Google) and foundation (i.e. Bill and Melinda Gates Foundation) financing. Position Location Senior Director, Regulatory Affairs New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide high level Regulatory Affairs advice, identify regulatory requirements and set regulatory strategy for international vaccine development 2) Participate in the Research and Development Management Committee (RDMC) to ensure continuous regulatory support of development projects 3) Communicate complex and unusually complicated regulatory information and tactical issues to management 4) Participate on project teams and direct activities to ensure regulatory compliance in pre-clinical, clinical plans and manufacturing 5) Assess scientific data for registration purposes against regulatory requirements 6) Review and critique technical documents from pharmacology/toxicology, CMC, clinical and biostatistical 7) Prepare, review and submit all necessary regulatory information to regulatory agencies worldwide 8) Maintain awareness of international regulatory legislation and assess its impact product development programs. Review applicable regulatory proceedings and maintain awareness of and report potential impact of regulations to RDMC 9) Manage an effective regulatory team, including a diverse group of global regulatory consultants 10) Direct the preparation of responses to health authorities and other regulatory correspondence. May take the lead in preparing such correspondence Requirements 1) Ph. D./M.D. or MPH degree together with extensive experience in vaccine development 2) 5+ years experience in Regulatory Affairs with bio-pharmaceutical products and 3+ years experience in another aspect of bio-pharmaceutical product development (clinical, pre-clinical, or CMC development) 3) The technical experience must include thorough knowledge of vaccine development with clinical, regulatory affairs experience, along with experience in CMC, and/or pharmacology, toxicology and/or biostatistical analysis 4) Skilled at gathering regulatory intelligence and developing product approval strategies 5) Proven ability to manage critical projects as a part of an interdisciplinary team 6) Excellent skills in managing regulatory affairs professionals 7) Proven ability to successfully interact with regulatory authorities 8) Prior experience managing regulatory submissions with the ability to successfully manage project to deadlines 9) Thorough understanding of relevant vaccine development regulations and guidelines 10) Proficient with computer and standard software programs 11) Outstanding interpersonal and communication (written and verbal) skills