Position Summary
Acrivon Therapeutics is seeking an accomplished and strategic Vice President or Senior Vice President of Regulatory Affairs to lead the global regulatory function and serve as a key member of the Development Leadership Team. This individual will be responsible for developing and executing innovative regulatory strategies that accelerate the advancement of Acrivon's precision oncology pipeline from early clinical development through registration and commercialization.
The successful candidate will lead regulatory strategy across all development programs, working closely with clinical, translational medicine, biomarker, CMC, quality, and executive teams. This person will serve as the primary regulatory liaison to global health authorities and help shape development strategies that advance Acrivon's precision medicine approach while ensuring compliance with global regulatory requirements. This position is based onsite at Acrivon Therapeutics' headquarters in Watertown, Massachusetts.
Key Responsibilities
Regulatory Leadership & Strategy
- Develop and execute global regulatory strategies for Acrivon's oncology pipeline, including companion diagnostic and biomarker-driven development programs.
- Provide strategic regulatory guidance across all stages of development, from preclinical through commercialization.
- Lead regulatory planning for INDs, CTAs, ODDs, end-of-Phase meetings, breakthrough therapy designations, accelerated approval pathways, NDAs, BLAs, MAAs, and other key regulatory milestones.
- Evaluate evolving global regulatory requirements and proactively assess their impact on company programs and strategy.
- Serve as the primary regulatory advisor to executive leadership and the Board of Directors as needed.
Health Authority Interactions
- Lead all interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other regulatory agencies.
- Develop briefing documents, meeting strategies, and negotiation approaches for regulatory interactions.
- Represent the company during regulatory meetings and inspections.
- Build and maintain productive relationships with regulatory agencies and external regulatory experts.
Regulatory Operations & Submissions
- Oversee preparation, review, and submission of regulatory filings and correspondence.
- Ensure high-quality, compliant, and timely regulatory submissions.
- Provide strategic oversight for submission planning, document development, and regulatory publishing activities.
- Establish and maintain regulatory processes, systems, and standards that support organizational growth.
Cross-Functional Leadership
- Partner closely with Clinical Development, Clinical Operations, Translational Medicine, Biomarker Sciences, Medical Affairs, CMC, Quality, Legal, and Program Management teams.
- Integrate regulatory strategy into overall development and business objectives.
- Provide regulatory leadership for companion diagnostic and precision medicine development initiatives.
- Support diligence activities, partnership discussions, and business development opportunities as needed.
People Leadership
- Foster a culture of accountability, collaboration, scientific rigor, and continuous improvement.
- Manage external consultants, CROs, and regulatory vendors as appropriate.
- Scale regulatory capabilities to support company growth and pipeline expansion.
Qualifications
Required
- Advanced scientific degree (PhD, PharmD, MD, or equivalent); additional regulatory certification is a plus.
- VP: Typically 15+ years of regulatory affairs experience in the biotechnology or pharmaceutical industry.
- SVP: Typically 20+ years of regulatory affairs experience with demonstrated executive leadership responsibilities.
- Significant experience leading regulatory strategy for oncology development programs.
- Proven success with INDs, global clinical development, and major health authority interactions.
- Experience supporting or leading regulatory activities associated with precision medicine, biomarkers, and/or companion diagnostics.
- Demonstrated track record of regulatory achievements that have advanced products through key development milestones.
- Strong understanding of U.S. and international regulatory frameworks and expedited development pathways.
- Exceptional leadership, communication, negotiation, and influencing skills.
Preferred
- Experience supporting NDA, BLA, MAA, or equivalent marketing applications.
- Prior experience in a clinical-stage oncology biotechnology company.
- Experience working within highly collaborative, fast-paced, entrepreneurial environments.
- Familiarity with AI-enabled, biomarker-driven, or precision medicine development approaches.
