Senior Director, Regulatory CMC
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Job Description
Senior Director leading Regulatory CMC strategy for Centessa Pharmaceuticals’ small-molecule medicines. Overseeing global submissions, late-stage development, CDMOs, and manufacturing readiness.
Responsibilities:
- Develop and execute integrated Regulatory CMC strategies for small molecule programs from preclinical development through late-stage clinical development and regulatory submissions
- Provide strategic and technical leadership across drug substance, drug product, analytical development, manufacturing, and control activities
- Serve as Regulatory CMC subject matter expert on cross-functional program teams
- Provide regulatory guidance on development plans, regulatory risk assessment, lifecycle management, and health authority expectations
- Lead preparation, review, and approval of CMC content for global regulatory submissions and responses, including INDs, CTAs, marketing applications, supplements/variations, briefing packages, and health authority information requests
- Monitor and interpret evolving global regulatory requirements, guidance, and precedent
- Manage external development and manufacturing partners, including CDMO selection, oversight, performance management, technology transfer, scale-up, validation, and manufacturing readiness
- Ensure compliance with FDA, EMA, ICH, and cGMP expectations while supporting inspection readiness and supply continuity
- Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies
- Build effective relationships with internal stakeholders and external partners
Requirements:
- Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; PharmD or PhD preferred
- Minimum of 12 years of pharmaceutical industry experience, including at least 5 years in Regulatory CMC roles supporting small molecule development programs
- Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions
- Experience authoring, reviewing, and managing CMC regulatory filings, including INDs, IMPDs, NDAs, and global health authority interactions
- Strong knowledge of small molecule drug substance and drug product development, analytical development, manufacturing processes, control strategies, and pharmaceutical development principles
- Extensive experience managing CDMOs and external development and manufacturing organizations
- Thorough understanding of cGMP requirements, ICH guidelines, FDA regulations, and global Regulatory CMC expectations
- Experience supporting programs from early development through IND submission and lifecycle management
- Experience supporting technology transfer, process development, scale-up, validation, and clinical supply manufacturing activities
- Excellent leadership, project management, communication, and cross-functional collaboration skills
- Experience in orexin, CNS, or other specialty therapeutic areas preferred
Benefits:
- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision, and prescription drug benefits
- Healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
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