Senior Director, Regulatory CMC

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company; Boston (MA); On-site; USD 185,000 - 250,000; Full time

Benefits offered by this job

401(k) plan

Health insurance

Dental coverage

Vision insurance

Life insurance

Paid time off

Wellness program

Job summary

Centessa Pharmaceuticals in the US seeks a Senior Director, Regulatory CMC to provide strategic and operational leadership for Regulatory CMC activities across small molecule programs.

You will lead CMC initiatives, develop global regulatory strategies, partner with stakeholders, and oversee CMC submissions including INDs, NDAs, and variations. This role demands extensive experience with outsourced development and manufacturing and strong regulatory expertise.

Qualifications

• Master's degree in Chemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum of 12 years in pharmaceutical industry, including at least 5 years in Regulatory CMC roles supporting small molecule programs.
• Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions.

Responsibilities

• Develop and execute integrated Regulatory CMC strategies from preclinical through late-stage clinical development and regulatory submissions.
• Provide strategic leadership across drug substance, drug product, analytical development, manufacturing, and control activities.
• Serve as Regulatory CMC expert on cross-functional program teams, aligning CMC plans with clinical, regulatory, quality, and business objectives.
• Provide regulatory guidance to CMC and program teams, driving decisions on development plans and lifecycle management.

Skills

Regulatory CMC leadership

IND/NDA submissions

CDMO management

FDA/ICH/EMA knowledge

Cross-functional leadership

Oroxin/CNS experience

Education

Master's degree in Chemistry/ Pharmaceutical Sciences

PharmD or PhD preferred

Job description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.

Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.

Description of Role

As the Senior Director, Regulatory CMC, you will provide strategic and operational leadership for Regulatory CMC activities across the company's small molecule development programs. Reporting to the Executive Director, Regulatory CMC, you will lead Regulatory CMC initiatives, develop and execute global CMC regulatory strategies, partner with internal and external stakeholders, and oversee CMC regulatory submissions across our portfolio.

The ideal candidate brings experience supporting small molecule programs from early development through regulatory submission, including IND- and NDA-supporting activities. While broad lifecycle experience is highly desirable, recent, hands‑on leadership of late-stage development programs, NDA‑enabling activities, and marketing application submissions is required. The successful candidate will have strong expertise in outsourced development and manufacturing and a proven ability to drive regulatory readiness and execution in a fast-paced environment.

Key Responsibilities

• Develop and execute integrated Regulatory CMC strategies supporting 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 to support clinical development, regulatory submissions, and future commercialization.
• Serve as the Regulatory CMC subject matter expert on cross-functional program teams, ensuring alignment of CMC development plans with clinical, regulatory, quality, and business objectives.
• Provide strategic regulatory guidance to CMC and program teams, driving informed decision-making related to development plans, regulatory risk assessment, future lifecycle management, and health authority expectations.
• Lead the 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, incorporating innovative regulatory approaches to support efficient product development and registration strategies.
• Manage external development and manufacturing partners, including CDMO selection, oversight, performance management, technology transfer, scale-up, validation, and manufacturing readiness activities.
• Ensure compliance with applicable global regulatory requirements, including 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 while building effective partnerships with internal stakeholders and external collaborators.
• Build effective relationships with internal stakeholders and external partners to support program advancement and organizational goals.

Qualifications

• 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, is required.
• Proven 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.
• Demonstrated 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 is preferred.

Compensation

The annual base salary range for this position is $175,000.00 to $260,000.00. Individual compensation within this range will be determined based on a variety of factors, including -qualifications, skills, relevant experience, job knowledge and location.

In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.

Work Location

The Senior Director, Regulatory CMC role is based in the US, with occasional travel.

POSITION:Full-Time, Exempt

EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.