VP/SVP Regulatory Affairs - Global Oncology Strategy

Integratedcooling; Watertown (MA); On-site; USD 280,000 - 420,000; Full time

Job summary

Acrivon Therapeutics, Inc. is seeking an accomplished Vice President or Senior Vice President of Regulatory Affairs to lead the global regulatory function and drive strategic activities across the oncology pipeline from early development through registration.

The role requires leading regulatory strategy, managing interactions with FDA, EMA, and other authorities, and aligning regulatory plans with Clinical, CMC, and Quality teams. Onsite in Watertown, MA.

Qualifications

• Advanced scientific degree (PhD, PharmD, MD, or equivalent); regulatory certification is a plus.
• VP: typically 15+ years regulatory affairs experience; SVP: typically 20+ years with executive leadership.
• Significant experience leading regulatory strategy for oncology programs.
• Proven success with INDs, global development, and major health authority interactions.
• Experience with precision medicine, biomarkers, and companion diagnostics.

Responsibilities

• Develop and execute global regulatory strategies for oncology programs, including companion diagnostics.
• Provide strategic regulatory guidance across all development stages from preclinical to commercialization.
• Lead regulatory planning for INDs, CTAs, NDAs, BLAs, and other milestones.
• Oversee interactions with FDA, EMA, MHRA, PMDA, and other agencies; manage briefing documents and meetings.
• Partner with Clinical, CMC, Quality, Legal, and Program Management to integrate regulatory plans.

Skills

Regulatory leadership

Oncology development

Global authorities

Strategic planning

Executive communication

Education

PhD, PharmD, MD, or equivalent

Job description

Acrivon Therapeutics, Inc. is seeking an accomplished Vice President or Senior Vice President of Regulatory Affairs to lead the global regulatory function and drive strategic activities across the oncology pipeline from early development through registration.

The role requires leading regulatory strategy, managing interactions with FDA, EMA, and other authorities, and aligning regulatory plans with Clinical, CMC, and Quality teams. Onsite in Watertown, MA.