Head of Global Regulatory Affairs and Strategy, Cambridge, MA

About the role

The experienced and visionary Head of Global Regulatory Affairs and Strategy will lead regulatory strategy for all assets from IND to POC to registration and leverage AI to advance initiatives to transform regulatory pathways. Reporting to the Chief Medical Officer, this role will be the founding architect of our Regulatory function, responsible for building the team, systems, and vendor ecosystem required to transition into a clinical-stage organization.

Responsibilities

• Define and continuously optimize global regulatory strategies for development programs.
• Formulate overall regulatory strategies, optimize the filing pathways, mitigate registration risks, and ensure the achievement of filing milestones.
• Establish scalable regulatory capabilities, processes, systems, and standards appropriate for a lean startup environment, including Electronic Common Technical Document (eCTD) document management and submission planning.
• Architect and implement a phase-appropriate Quality Management System (QMS) to ensure GxP compliance and internal and external audit readiness.
• Establish the company’s global PV infrastructure, including safety reporting workflows and executive oversight of the benefit-risk profile for clinical assets.
• Define the Medical Writing strategy to ensure scientific narrative consistency across all regulatory dossiers.
• Serve as the primary point of contact for all regulatory interactions; lead the preparation and execution of meetings with global health authorities and Advisory Committees.
• Oversee the end-to-end lifecycle of regulatory findings, from initial IND/CTA submission through BLA/NDA/MAA registration and post-approval maintenance.
• Collaborate with internal AI/ML and Data Science teams to implement technology-driven solutions to streamline submission processes and enhance regulatory strategy and decision-making.
• Act as a key strategic partner to cross-functional stakeholders to ensure development plans, protocols, reports, and manufacturing changes are aligned with regulatory requirements and strategy.
• Monitor evolving global regulatory guidelines and expectations, and translate complex changes into actionable guidance for internal project teams.
• Accountable for global regulatory compliance activities, including GxP compliance, safety reporting, promotional materials, etc.
• Provide regulatory due diligence and strategic guidance to business development.
• Anticipate regulatory risks, propose mitigation strategies, and advise leadership on regulatory pathways, designations, and opportunities to accelerate development.
• Select and manage strategic vendors and consultants.
• Host FDA/third party regulatory audits and ensure follow up on findings/observations issued.

Skills and qualifications

• Education: Bachelor’s in life sciences or related field; advanced scientific or pharmacy degree preferred.
• Experience: 15+ years in the pharmaceutical/biotech industry, with extensive experience leading programs from early development (IND/CTA) through successful registration (NDA/BLA/MAA), preferably with oncology and inflammation experience.
• Track record: Extensive experience leading regulatory strategy and health authority interactions for clinical-stage assets. Expertise with the development and preparation of regulatory submissions including briefing books, INDs, and NDA/BLAs (including expedited pathways). Proven ability to align stakeholders to understand their critical roles and responsibilities in regulatory submission. A high impact communicator with the ability to influence executive level decisions and represent the company to regulatory authorities.
• Knowledge Base: Profound knowledge of global registration processes, ICH guidelines, and direct experience serving as the primary liaison to global health authorities. Working familiarity with GxP requirements and fundamental components of PV and Quality Management Systems.
• Leadership Effectiveness: Demonstrated success in building and mentoring high-impact Regulatory teams in a fast-paced, matrixed environment. Strong project management, cross-functional coordination, interpersonal skills, conflict resolution, and negotiation skills in multifunctional matrixed and global environments.