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.