New · posted Oct 15
Centessa Pharmaceuticals (UK) · Pharmaceuticals
Senior Director, Regulatory CMC
- Boston, MA
- On-site
- Full-time
- Director
Open until filled
The role
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.
The Senior Director, Regulatory CMC role is based in the US, with occasional travel.
What you need
- 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.
What you'll do
- 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.
Pay and benefits
$175,000 – $260,000 a year
Employer providedThe 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.
Discretionary annual bonus
401(k) plan
Medical, dental, vision insurance
Life insurance
Paid time off
Health and wellness program
Where you'll work
Boston, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Boston, MAFrom the posting
About Centessa Pharmaceuticals (UK)
Work Location
POSITION: Full-Time, Exempt
Equal opportunity, accessibility and legal noticesCentessa Pharmaceuticals (UK)'s statements, word for word
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.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 4% above the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Director roles in Massachusetts20 roles publishing pay
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $175,000 | — | $260,000 |
| Massachusetts (middle half) | $199,625 | $222,500 | $244,125 |
| All US (middle half) | $190,500 | $210,000 | $244,500 |
This role: Centessa Pharmaceuticals (UK)'s own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 82 open Regulatory CMC roles on Regulatory Jobs, with the titles they carry most. Not Centessa Pharmaceuticals (UK)'s own promotion track.
Career resources on Regulatory CMC
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Regulatory submissions9
- Lab testing and methods3
- GMP and compliance2
- Validation and qualification2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
Company hiring pulse
Centessa Pharmaceuticals (UK) on Regulatory Jobs
- 6
- Open roles
- 6
- Distinct roles
- 2
- Locations
By discipline
- Regulatory3 50%
- Quality3 50%
By level
- Director5 83%
- Manager1 17%
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Senior Director, Regulatory CMC at Centessa Pharmaceuticals (UK)
Open until filled. $175K–$260K a year, employer provided.