Hiring: Senior Director, Global Regulatory Strategy Company: Centessa Pharmaceuticals Location: Boston, MA Job Posted Time: 2026-09-15 11:46:32 Employment Type: Full-time About the job Experience: •12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, including 5+ years in a global regulatory leadership role. Required Skills: •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. Qualifications: •Bachelor's degree in a scientific discipline with 12+ years of progressive regulatory affairs experience within the pharmaceutical or biotechnology industry, including 5+ years in a global regulatory leadership role. •Advanced degree (PhD, PharmD, MS, or JD) and experience supporting small molecule development strongly preferred. •Significant NDA leadership experience, including direct responsibility for NDA strategy, submission, and regulatory review activities in a sponsor organization. •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. Compensation: •$225,000 - $275,000 / year •Competitive benefits and rewards package •In addition to base pay, this role is eligible for a discretionary annual bonus Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!