Vice President, Head of Regulatory Affairs

This is a Retained Search.  Our client is unlocking the power of the human immune system to treat cancer, as well as autoimmune and infectious diseases. They are seeking a Vice President, Head of Regulatory Affairs who can drive regulatory strategy and execution for their clinical and pre-clinical programs and also build out their Regulatory function. This company has a unique, propriety discovery & development platform along with two programs in Phase 1 clinical trials. Now is an exciting time to join this fast-paced company and help get innovative medicines approved!

Responsibilities:

  • Develop and lead regulatory strategies for targeted immune medicines (for oncology and other indications) in the US and globally.
  • Partner with and support clinical development, CMC, preclinical, quality, medical affairs, commercial and corporate activities
  • Plan and build a robust regulatory organization, processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy.
  • Act as primary strategic contact with the FDA and other regulatory agencies to enable execution of company regulatory goals.
  • Provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
  • Utilize regulatory expertise and knowledge of regulatory requirements to strategically interpret, plan, and communicate requirements and ensure governmental approvals are obtained.
  • Work collaboratively with clinical development functions and other early development functions to help design integrated product specific development plans.
  • Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities.
  • Develop and plan innovative regulatory strategies for label enhancements and life cycle product management collaboratively with project team members.
  • Provide regulatory strategic leadership supporting commercialization and post-marketing activities and requirements for approved products.
  • Build and manage a team of U.S. Regulatory staff and support functions including full time staff and independent consultants based on the stages of the business.
  • Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future company products
  • Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to company employees and assist as a liaison with regulatory authorities.
  • Communicate complex and unusually complicated regulatory information and tactical issues to management.

Qualifications:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD, MD or PhD) preferred.
  • 15+ years of industry experience with 10+ years in Regulatory Affairs for biopharmaceuticals
  • Must have Regulatory leadership and/or team management experience.
  • Expertise leading, designing, writing, and submission of regulatory filings and correspondence and/or approvals is required
  • Regulatory expertise within Oncology or Immune-Oncology space.
  • Experience with biologic therapeutics is a must. Experience in the cell therapy space is desired but not required.
  • Strong understanding of the global pharmaceutical drug development and regulatory environment particularly within the FDA.
  • Experience leading the submission process for INDs, new entities, and line extensions of existing products preferred.
  • In-depth understanding of the drug development, product commercialization, and life cycle management processes. Experience in Quality Assurance, Development, Clinical, and Compliance is a plus.
  • Strong collaboration, leadership competencies, and strategic business perspectives are required.
  • Experience and/or active involvement in joint ventures, highly collaborative partnerships, and in/out-licensing business opportunities is a plus.
  • Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
  • Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory, and scientific standards.
  • Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused with the ability to think strategically as well as execute project details.
  • Has evidence of strategic regulatory thinking: working collaboratively to create novel, creative solutions to regulatory issues.
  • Strong collaborative and transformational leadership skills with potential for further growth.
  • Must be comfortable in a small company environment. Must be flexible and comfortable with ambiguity.

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