Vice President of Regulatory Affairs

We have been retained to find a Vice President of Regulatory Affairs to join a growing immuno-oncology company.  You will serve as the senior regulatory strategist supporting a pipeline of next-generation immunotherapies that target the tumor microenvironment.  You will lead the development, planning, and execution of the regulatory strategy to facilitate the achievement of the company’s short and long-term objectives while also building the regulatory team and infrastructure needed to support their growing pipeline.  This is an exciting time to join this growing organization and help get innovative programs approvd!


  • Lead and manage the company’s global regulatory function to ensure research and development objectives are met
  • Provide hands-on, solution-oriented advice regarding all regulatory matters
  • Lead, develop and implement a regulatory strategy to meet company goals and objectives
  • Facilitate problem-solving and drive decision-making around complex regulatory, preclinical, clinical and CMC development issues
  • Serve as advisor and strategic partner to the CMO, CEO, executive clinical development team and the Board of Directors on all regulatory matters
  • Provide direction and counsel regarding compliance with all applicable laws and regulations, and staying abreast of changing guidance, regulatory developments and developing external trends
  • Lead and facilitate meetings with regulatory agencies and prepare internal teams for these interactions
  • Oversee the establishment and maintenance of the RA programs, policies, and procedures
  • Ensure regulatory support of pharmaceutical development, manufacturing operations, conduct of clinical and nonclinical studies, and marketing and sales activities
  • Oversee regulatory filings to ensure accuracy, quality and compliance
  • Collaborate with partners to ensure successful global development, registration planning and implementation
  • Lead and develop RA staff to ensure ongoing professional development


Requirements and Skills:

  • Bachelor’s degree in life sciences or a related field required. Advanced degree preferred
  • At least 15 years’ experience in the pharmaceutical/biotechnology industry within Regulatory Affairs function, with particular expertise with biologics in oncology
  • Demonstrated success in fast-paced rapid growth environments is strongly preferred
  • Outstanding executive leadership and management skills in all aspects of a regulatory environment, with proven ability to advise a successful and growing company
  • Exceptional interpersonal skills and the ability to communicate effectively with senior leaders and other professionals and colleagues at all levels of an organization while utilizing excellent regulatory judgment in complex situations
  • Strong knowledge of applicable regulatory requirements including but not limited to GXPs
  • Significant previous experience interacting with FDA, EMA and other regulatory agencies
  • Very strong written and verbal skills

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