Senior Director, Global Regulatory Strategy

Centessa Pharmaceuticals•Boston, MA

2d•Onsite

About The Position

Centessa Pharmaceuticals, a clinical-stage company developing orexin receptor 2 (OX2R) agonists for narcolepsy and other sleep-wake disorders, is seeking a Senior Director, Global Regulatory Strategy. This role reports to the VP, Regulatory and Medical Writing and serves as a key member of the regulatory team, providing strategic and operational regulatory leadership across global development programs. The position requires developing and executing global regulatory strategies for assigned assets, including leading NDA planning, preparation, and submission. The role involves extensive experience managing interactions with health authorities like the FDA and other international agencies, providing regulatory guidance to cross-functional teams, and leading regulatory sub-teams. Direct people management experience, success in a matrixed organization, and the ability to oversee external consultants and vendors are essential. The company was recognized as a Great Place to Work ® in 2026.

Requirements

Bachelor's degree in a scientific discipline
12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry
5+ years in a global regulatory leadership role
Significant NDA leadership experience, including direct responsibility for NDA strategy, submission, and regulatory review activities in a sponsor organization.
Recent significant experience with regulatory submission strategy, structure, and content, including NDAs, INDs, CTAs, and other global regulatory filings.
Demonstrated track record of successful regulatory interactions with the FDA, EMA, and other global health authorities supporting major submissions and product approvals.
Proven success serving as the Global Regulatory Lead for development and registration-stage programs within a matrixed environment, including direct people management experience.
Extensive knowledge of nonclinical and clinical drug development, FDA, ICH, EMA, EU National Competent Authority, MHRA, and other applicable global regulatory requirements and guidelines.
Strong experience leading cross-functional teams and providing strategic regulatory guidance to development programs from early development through registration and lifecycle management.
Excellent written, verbal, presentation, and influencing skills, with the ability to communicate complex regulatory strategies and risks to senior management, health authorities, consultants, and external partners.
Proven analytical, problem-solving, organizational, negotiation, and decision-making skills, with the ability to develop regulatory strategies and compelling, data-driven regulatory narratives.
Demonstrated ability to thrive in a fast-paced, innovative environment while fostering collaboration, open communication, and alignment among diverse stakeholders.

Nice To Haves

Advanced degree (PhD, PharmD, MS, or JD)
Experience supporting small molecule development

Responsibilities

Serve as the Global Regulatory Lead for assigned development programs, providing strategic regulatory leadership from early development through registration and lifecycle management.
Develop and execute global regulatory strategies to obtain, maintain, and expand product registrations across multiple regions and health authorities.
Lead the planning, preparation, and submission of major regulatory filings, including INDs, NDAs, briefing documents, and other regulatory submissions within scope of responsibility.
Represent the company in regulatory interactions and lead meetings with global health authorities, including the FDA and other international regulatory agencies.
Provide regulatory guidance and strategic input to cross-functional program teams, ensuring regulatory considerations are integrated into development plans and key business decisions.
Lead regulatory sub-teams and represent Regulatory Affairs on cross-functional governance and program teams, driving alignment among internal stakeholders and senior leadership.
Manage, develop, and mentor regulatory staff, fostering professional growth and building organizational capability within the Regulatory Affairs function.
Ensure ongoing compliance with applicable regulatory requirements and guidance, communicating regulatory developments and implications to relevant stakeholders.
Partner with the VP, Regulatory and Medical Writing and broader Regulatory Affairs leadership to strengthen departmental capabilities, operational excellence, and efficient execution across the portfolio.
Identify, engage, and oversee external regulatory consultants and vendors to support the successful execution of regulatory strategies and submissions.