SVP/VP, Global Head of Regulatory Affairs

SVP/VP, Global Head of Regulatory Affairs This job posting expired and applications are no longer accepted. This job posting was marked by employer as filled and is probably no longer available Location Greater Boston Area, United States of America Job Type Full-time Description SVP/VP, Global Head of Regulatory Affairs | Confidential | RETAINED SEARCH 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. Responsibilities Responsible 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 / Requirements Advanced 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. Contact Thomas J. Fascia Email: tfascia@cornerstonesg.com Phone: 973-656-0220x717 LinkedIn: https://www.linkedin.com/in/thomasfascia Cornerstone Search Group, LLC 1200 Morris Turnpike | Short Hills, New Jersey 07078, USA www.cornerstonesg.com Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission. Back To Featured Searches List Manage Consent To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behavior or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions. 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