SVP, Regulatory Affairs

Vice President/Senior Vice President, Regulatory Affairs*Candidates should be based in New England or must be flexible to travel*Key ResponsibilitiesYou will provide regulatory leadership and provide strategic direction to Regulatory Affairs, Clinical Quality, Medical Writing departments and lead Regulatory Affairs group, including hiring, mentoring, and leading staffDrive the planning and implementation of meetings with regulatory authorities and effectively represent the client's regulatory interactionsDirect and negotiate submissions (IND, CTA, BLA, MAA etc..) and approvals with regulatory authoritiesKey QualificationsBS required, MS/PhD/PharmD preferred15+ years of Regulatory Affairs experienceExperience in virology/infectious disease requiredExperience leading programs from Initial IND/CTA through BLA/MAAExtensive Health Authority interaction experience (FDA, EMA, Health Canada)

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