The VP/SVP, Head of Regulatory Affairs will provide strategic and operational leadership for the Company's global regulatory function and serve as a key member of the leadership team. This individual will be responsible for developing and executing global regulatory strategies across the Company's oncology portfolio, from early development through registration and lifecycle management. The role will lead interactions with global health authorities, provide regulatory guidance to executive leadership and cross-functional development teams, and build and lead a high-performing Regulatory Affairs and Medical Writing organization.
Key Responsibilities- Global Regulatory Strategy: Develop and execute integrated global regulatory strategies across the Company's oncology portfolio, from early development and IND-enabling activities through clinical development, registration, commercialization, and lifecycle management. Ensure regulatory strategies are aligned with corporate and product development objectives.
- Clinical Development Strategy: Provide strategic regulatory guidance on clinical development plans, target product profiles, pivotal trial design, registration pathways, and global development sequencing. Partner closely with Clinical Development, Biostatistics, Clinical Operations, CMC, and other functions to optimize development and registration strategies.
- Regulatory Submissions & Approvals: Lead and oversee the preparation, submission, and management of major regulatory applications, including INDs, BLAs, MAAs, and other global submissions. Drive regulatory strategy and execution toward timely approvals across key markets.
- Health Authority Interactions: Serve as the senior regulatory representative and lead key interactions and negotiations with the FDA, EMA, and other global health authorities, including Pre-IND, End-of-Phase, Type B/C, pre-BLA and other critical regulatory meetings.
- Regulatory Risk Management & Intelligence: Proactively identify regulatory risks, opportunities, and evolving requirements; develop mitigation strategies and leverage regulatory intelligence and competitive insights to inform development and business decisions.
- Medical Writing Oversight: Provide strategic oversight of Medical Writing activities to ensure high-quality, scientifically rigorous, and timely regulatory and clinical documentation supporting global development and submissions.
- Organization & Team Leadership: Build, develop, and lead a high-performing Regulatory Affairs and Medical Writing organization. Establish scalable processes, capabilities, and infrastructure to support the Company's growing global portfolio while mentoring and developing team members.
Qualifications- Advanced degree in life sciences, medicine, pharmacy, or a related field (MD, PhD, PharmD, or equivalent) preferred.
- 15+ years of progressive Regulatory Affairs experience within the biotechnology or pharmaceutical industry, including significant experience in senior leadership roles.
- Extensive experience in oncology drug development and global regulatory strategy is strongly preferred. Experience with biologics, antibody-drug conjugates (ADCs), bispecific/multispecific antibodies, or other complex therapeutic modalities is highly desirable.
- Demonstrated track record of leading major regulatory submissions, including INDs and preferably successful BLA/MAA filings and approvals.
- Extensive experience leading interactions and negotiations with the FDA and other global health authorities, with demonstrated ability to navigate complex regulatory issues and achieve alignment on development and registration strategies.
- Strong understanding of clinical development, with demonstrated ability to provide strategic regulatory guidance on clinical development plans, pivotal trial design, registration pathways, expedited development programs, and lifecycle management.
- Demonstrated ability to develop and execute integrated global regulatory strategies across the U.S., Europe, China, and other key markets.
- Proven experience building, developing, and leading high-performing Regulatory Affairs teams.
- Strong scientific and business acumen, with the ability to establish credibility and collaborate effectively with Clinical Development, CMC, Quality, Medical Affairs, Commercial, and other cross-functional stakeholders.
- Exceptional leadership, communication, influencing, and problem-solving skills, with strong executive presence and the ability to operate effectively in a fast-paced, entrepreneurial, and global biotechnology environment.
Compensation and Benefits:The expected base salary range for this position is $340,000 - $420,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate's level qualifications, experience, and skills.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
