Senior Director or VP of Regulatory Affairs

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, guidance, and industry trends and translate relevant changes into actionable strategies to ensure continued compliance
• Manage and coordinate with external regulatory consultants and vendors, ensuring appropriate expertise, accountability, quality, timelines, and cost-effectiveness while meeting deliverables
• Build regulatory capabilities across the organization through mentoring, training, and clear communication of regulatory expectations, program deliverables, and best practices

Qualifications:

• Advanced degree in life/health sciences or healthcare related field with 12+ years of relevant life science industry experience, or Bachelor's degree with 15+ years of relevant experience
• 5+ years of progressive leadership experience in Regulatory Affairs, including experience leading a Regulatory function or major regulatory program within a biotechnology or pharmaceutical company, small biotechnology experience is preferred
• Experience operating at the executive level and partnering effectively with senior leadership on complex regulatory and business decisions
• Proven experience leading major regulatory submissions for oncology products, including successful BLA and IND submissions; experience with multiple successful BLA submissions is strongly preferred
• Demonstrated deep understanding of US regulatory landscape, frameworks, and FDA requirements applicable to oncology drug development and commercialization, including compliance and quality guidelines and standards
• Demonstrated expertise developing and executing regulatory strategies across the product lifecycle, from clinical development to approval and, ideally, post-approval activities
• Experience developing global regulatory strategies and engaging with the FDA, EMA, and/or other major health authorities
• Comprehensive understanding of oncology drug development and the regulatory considerations spanning clinical, nonclinical, CMC, quality, pharmacovigilance, and commercialization activities
• Proven ability to lead, push timelines, and motivate in cross-functional teams and influence internal and external stakeholders in a fast-paced, diverse, collaborative team
• Adept at assessing complex regulatory issues, anticipating risks, incorporating diverse input, and translating regulatory considerations into clear recommendations for senior leadership
• Ability to prepare executive-level presentations from data analytics and metrics, to inform decisions and optimize project outcomes
• Ability to manage multiple complex programs and regulatory priorities while maintaining focus on critical company milestones
• Experience effectively managing regulatory consultants, CROs and external partners
• Strong business judgment, strategic thinking, and problem-solving skills, with the ability to balance competing priorities and timelines, and make decisions in an evolving environment
• Excellent written and verbal business communication skills, including the ability to effectively present complex regulatory information to executives, Board, and external health authorities