Group Vice President – Global Regulatory Affairs

The Group Vice President, Global Regulatory Affairs will provide enterprise-level regulatory leadership across the company’s development and commercial portfolio, shaping global regulatory strategy from early development through approval and lifecycle management.

As the senior leader within the organization, this individual will serve as a strategic advisor to executive leadership and cross-functional development teams, providing regulatory perspective on portfolio strategy, development pathways, regulatory risk, and opportunities to accelerate programs while maintaining the highest standards of scientific and regulatory rigor.

The GVP will lead global regulatory strategy for early- and late-stage biologic programs and approved products, including pivotal Health Authority interactions, global submissions, registrations, and lifecycle strategies. This leader will also bring regulatory insight to the evaluation of new therapeutic opportunities and due diligence, helping inform investment and development decisions across the portfolio.

The individual will lead and further develop the Global Regulatory Affairs organization, including oversight of Global Medical Safety, and will establish strong partnerships across Clinical Development, Medical, Safety, CMC, Commercial, Legal, and other key functions. The role will represent the company with FDA, EMA, and other Health Authorities globally.

This role is based in our Lexington, MA office and requires employees to be onsite five days per week. Significant collaboration will be required with all core functions in the USA and Europe

Responsibilities (including, but not limited to):

Global Regulatory & Portfolio Strategy

• Define and lead U.S. and global regulatory strategies across development-stage and commercial programs, aligning regulatory pathways with clinical development plans and corporate objectives.
• Serve as a senior regulatory advisor to executive leadership, providing clear perspective on regulatory opportunities, precedent, risk, and implications for portfolio and investment decisions.
• Shape regulatory strategy for early- and late-stage development programs, identifying opportunities to accelerate development and optimize pathways to approval.
• Provide regulatory leadership in the evaluation of new therapeutic opportunities, including regulatory due diligence and assessment of development pathways and risks.
• Lead regulatory strategy for approved products, including global registrations, labeling strategy, lifecycle management, and expansion opportunities.

Health Authority Leadership

• Lead the company’s strategy and engagement with FDA, EMA, and other Health Authorities worldwide, including high-impact regulatory interactions, negotiations, and milestone meetings.
• Establish regulatory positions and ensure the organization is prepared to communicate clear, scientifically grounded strategies to global Health Authorities.
• Provide senior leadership for major regulatory submissions, including BLAs, NDAs, MAAs, and significant post-approval filings.

Development & Cross-Functional Leadership

• Serve as the senior regulatory leader across cross-functional development teams, ensuring regulatory strategy is integrated into clinical, CMC, safety, and commercial decision-making.
• Make strategic contributions to clinical development plans, including indication strategy, evidence requirements, endpoint considerations, development sequencing, and registration planning.
• Partner closely with Clinical Development, Medical, Global Medical Safety, CMC, Commercial, Legal, and other functions to drive timely portfolio decisions.

Organizational Leadership

• Lead, develop, and scale a high-performing Global Regulatory Affairs organization capable of supporting the company’s evolving development and commercial portfolio.
• Provide leadership and oversight to the Global Medical Safety function.
• Develop regulatory talent and succession capability while fostering a culture of accountability, collaboration, urgency, and sound judgment.
• Establish and maintain regulatory governance, policies, standards, and operating practices that support organizational growth and inspection readiness.
• Ensure compliance with applicable FDA, EMA, ICH, and global regulatory requirements

Standout Skills for Impact:

Executive Influence
Communicates complex regulatory considerations with clarity and conviction, enabling executive leadership and cross-functional teams to make informed decisions around opportunity, risk, and development strategy.

Urgency with Judgment
Operates with pace and accountability while maintaining scientific integrity, regulatory compliance, and sound risk-based decision-making.

Builder of High-Performing Teams
Creates clear direction, develops talent, and builds an organization capable of operating with both strategic depth and executional excellence.

Qualifications and Experience:

• Advanced degree in a relevant scientific, medical, or pharmaceutical discipline, PharmD/ PhD/ MS
• 15+ years of progressive Regulatory Affairs experience within the biopharmaceutical industry, including significant senior-level regulatory leadership experience.
• Proven track record developing and executing U.S. and global regulatory strategies across multiple stages of drug development.
• Successful leadership of BLA and/or NDA submissions and approvals.
• Extensive experience leading interactions with FDA and other global Health Authorities.
• Deep knowledge of global drug development and regulatory requirements, including FDA, EMA, ICH, and global registration pathways.
• Demonstrated ability to provide strategic regulatory counsel to senior leadership and influence complex cross-functional development and portfolio decisions.
• Proven ability to build, lead, and develop high-performing regulatory teams.
• Preferred experiences: MAA and broader global registration experience. Autoimmune, orphan, and/or expedited development programs, Regulatory CMC strategy and leadership, leveraging AI or emerging technologies within Regulatory Affairs