Senior Director or VP of Regulatory Affairs

About the role

Our Clinical Development team is seeking a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven track record of leading successful BLA submissions and desires to be part of a results-oriented, fast-paced, and collaborative team. This position reports to our CMO and is onsite 4 days/week in our office in Brighton, MA.

Responsibilities

• Lead the development and execution of the Company's Regulatory strategy, ensuring alignment with corporate objectives, clinical and commercial milestones, quality standards, and applicable regulations
• Serve as the company's senior Regulatory subject matter expert and strategic advisor to the Executive Leadership Team, providing regulatory perspectives that shape product development, corporate strategy, risk management, commercialization, and successful product approvals
• Build, lead, and scale the Regulatory function, establishing the capabilities, SOPs, systems, and external partnerships required to support the company's transition from clinical development through commercialization
• Develop proactive and coordinated US and ex-US regulatory strategies across the company's pipeline and ensure regulatory considerations are integrated into clinical, nonclinical, CMC, quality, pharmacovigilance, medical affairs, and commercial plans
• Provide regulatory leadership and strategic recommendations for development and product lifecycle plans, regulatory pathways, risk mitigation, and key business decisions such as label expansion and new indications
• Own the Company's regulatory strategy and cross-functional readiness for the tovecimig BLA, including overall regulatory planning, submission strategy, health authority engagement, and critical path activities
• Orchestrate and deliver successful IND and BLA filings, amendments, supplements, reports, meeting requests, briefing packages, and any regulatory submissions, ensuring high-quality, timely, consistent and coordinated submissions, that meet technical and regulatory requirements
• Effectively lead and partner closely with Clinical, CMC, Translational, Quality, Pharmacovigilance, Medical Affairs, Commercial, and other functions to integrate regulatory strategy into development and commercial plans and drive successful FDA interactions
• Provide regular regulatory updates to senior executives and the Board, as appropriate, including key milestones, risks, opportunities, agency feedback, and recommended actions to inform development, regulatory, and business decisions
• Serve as the primary Regulatory liaison and lead correspondent with the FDA, EMA, and other global health authorities, developing productive relationships and leading high-impact agency interactions; manage day-to-day interactions with regulatory authorities
• For each Clinical Program, establish regulatory plans, timelines, milestones, and budgets in order to track progress, proactively identify risks and constraints, and drive timely mitigation
• Coordinate and lead meetings with regulatory agencies including preparation and development of meeting strategies, briefing book roundtables and packages, cross-functional preparation, regulatory notifications, regulatory document workflows, agency interactions, responses to agency questions, and follow-up commitments
• Ensure effective regulatory submission planning, document governance, regulatory information management, and submission workflows
• Monitor evolving regulatory requirements,