New · posted Oct 15
Centessa Pharmaceuticals (UK) · Pharmaceuticals
Senior Advisor, Regulatory Starting Material
- 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
Centessa is currently seeking a Senior Advisor, Regulatory Starting Material. The individual in this Associate Director level role will lead the strategy, justification, and regulatory positioning of Regulatory Starting Materials for drug substance manufacturing processes supporting late-stage clinical and commercial programs. Reporting to the Vice President, CMC, this role will serve as the internal and external subject matter expert on RSM selection in accordance with ICH Q11 and applicable regional guidance, ensuring synthetic routes, GMP starting points, and supply strategies are scientifically sound, regulatorily defensible, and aligned with commercial manufacturing readiness. This individual will partner closely with Process Chemistry, Analytical Development, Regulatory Affairs, Quality, and external manufacturing partners to build and defend RSM strategy through health authority interactions and regulatory submissions.
What you need
- Advanced degree in chemistry, chemical engineering, or a related field; PhD strongly preferred.
- 8-10 years of relevant experience in CMC, process chemistry or drug substance/API development and manufacturing, including demonstrated leadership of starting material or CMC regulatory strategy programs.
- Demonstrated experience supporting late-stage clinical and/or commercial drug substance programs.
- Deep working knowledge of ICH Q11 and applicable regional guidance/expectations governing the selection and justification of Regulatory Starting Materials.
- Demonstrated experience authoring and defending CMC regulatory submission content, including direct experience in health authority interactions related to starting material or drug substance manufacturing strategy.
- Strong background in synthetic/process chemistry, with the ability to critically evaluate route scouting, impurity control strategy, and structural relevance arguments for candidate starting materials.
- Experience managing relationships with drug substance/API CMOs and raw material suppliers, including batch record reviews and overarching manufacturing oversight.
- Working knowledge of cGMP requirements as they apply to drug substance manufacturing and the GMP/non-GMP boundary.
- Experience supporting technology transfer of drug substance processes from clinical to commercial scale preferred.
- Strong leadership, cross-functional collaboration, and scientific writing/communication skills; exercises judgment within broadly defined practices and policies in determining solutions and actions.
- Demonstrated ability to identify and address starting material-related risks that could jeopardize regulatory timelines, supply, or overall program success.
What you'll do
- Lead the identification, justification, and regulatory strategy for Regulatory Starting Materials across drug substance synthetic routes, in accordance with ICH Q11 and relevant regional guidance/reflection papers.
- Actively manage the starting material resupply campaigns and scale-up efforts, including on-going inventory, production forecast, manufacturing timing, production suite slot reservations, and contracting.
- Author and review CMC regulatory submission content related to RSM selection and justification (e.g., Module 3 sections, briefing documents, agency responses) in support of INDs/NDAs /MAAs.
- Prepare and lead health authority interactions (e.g., Type C meetings, scientific advice procedures) related to starting material strategy; develop briefing packages and represent the company in agency discussions.
- Partner with Process Chemistry and Analytical Development to evaluate synthetic routes, assess structural relevance of candidate starting materials, and support impurity fate-and-purge and risk assessments that inform RSM designation.
- Define and document the boundary between non-GMP and GMP manufacturing steps for drug substance processes, ensuring alignment with CMOs and internal quality standards.
- Lead technology transfer and process changes affecting RSM designation as programs advance from late-stage clinical development toward commercial manufacturing.
- Manage relationships with drug substance/API CMOs and RSM suppliers, including technical oversight, site visits, and support for supplier qualification and dual-sourcing strategies.
- Monitor evolving global regulatory guidance and agency precedent on starting material selection; translate changes into updated internal strategy, templates, and risk assessments.
- Collaborate cross-functionally with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to ensure RSM strategy supports program timelines, submission readiness, and commercial supply continuity.
- Support due diligence activities (e.g., licensing, partnering) requiring assessment of drug substance manufacturing routes and starting material risk.
- Provide subject matter expertise during regulatory inspections and audits related to drug substance manufacturing and starting material justification.
- Build, lead, and mentor a team supporting RSM and drug substance CMC strategy activities (scope dependent on level).
- Domestic and international travel required (approximately 10–20%).
Pay and benefits
$140,000 – $210,000 a year
Employer providedThe annual base salary range for the Senior Advisor level position is $140,000.00 to $210,000.00.
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. The Company 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, and 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
The (Associate) Director, Regulatory Starting Material role is based in the US, with occasional travel.
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 17% below 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 | $140,000 | — | $210,000 |
| 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 28 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions8
- Documentation and SOPs5
- GMP and compliance4
- Quality systems and risk4
- Lab testing and methods2
- Investigations and CAPA1
- Validation and qualification1
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
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 Advisor, Regulatory Starting Material at Centessa Pharmaceuticals (UK)
Open until filled. $140K–$210K a year, employer provided.