SVP/VP, Global Head of Regulatory AffairsLocation: Greater Boston Area, United States of America
The Vice President / Senior Vice President & Global Head of Regulatory Affairs will report directly to the Chief Medical Officer of this clinical-stage biotechnology company developing ground-breaking cancer therapies and lead Global Regulatory Affairs for the company. In a nutshell, you will lead the development of regulatory strategy across the entire pipeline to ensure maximum regulatory success. In addition, you will be responsible for all activities associated with the regulatory submissions process both in the US and globally. Near-term responsibilities will include Regulatory strategy and execution of two Global Phase II studies.
ResponsibilitiesResponsible and accountable for the strategic direction, leadership, growth, tactical and operational success of the company's regulatory department.Develop and implement Global (primary focus on US and EU) regulatory strategies for the company and serve as the lead contact to the FDA and other Health Authorities.Lead the preparation and submission of regulatory applications to the FDA / other Health Authorities (ex-US) supporting clinical development programs and future marketing application filings. Create, organize, review and lead the preparation of all pre-filing and pre-approval submissions in accordance with FDA regulations.Build, lead and manage both internal and external Regulatory Affairs teams/vendors. Review current Regulatory Affairs structure and resources, determine and remedy any existing gaps, and develop regulatory SOPs for the company.Work closely with global regulatory vendors/colleagues in the preparation of ex-US regulatory submissions and alignment of regulatory strategies consistent with company goals and objectives.Qualifications / RequirementsAdvanced Degree: Ph.D., Pharm.D., MD, MS, or JD is required.20+ years of experience with a proven track record of success in Regulatory Affairs.10+ years of Oncology experience is required.5+ years of people management/direct report experience is required.A track record of significant and documentable accomplishments (success in filing BLA) in Regulatory Affairs is required.Experience leading a team filing and maintaining regulatory submissions.
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