New · posted Oct 15
Centessa Pharmaceuticals (UK) · Biotechnology
Associate Director, Regulatory Project Management
- 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
The Associate Director, Regulatory Project Management provides project management leadership across Global Regulatory Affairs, supporting assigned development programs and portfolio priorities. Serving as the central hub for regulatory projects, the Regulatory Project Manager (RPM) is accountable for regulatory project timelines, ensuring effective planning, tracking, execution, and delivery of submissions to health authorities worldwide.
The RPM partners across the Regulatory function to coordinate deliverables, maintain oversight of submission plans, and ensure regulatory documents are complete, accurate, and submitted on schedule. The role is responsible for maintaining project records and documentation to support compliance, audit readiness, and regulatory transparency. The RPM also provides regular updates to leadership and key stakeholders, communicating project status, risks, challenges, and milestones to ensure alignment and informed decision-making.
Success in this role requires strong organizational, communication, problem-solving, and time management skills, with keen attention to detail and the ability to manage multiple priorities while navigating evolving regulatory requirements and project constraints.
The Associate Director, Regulatory Project Management role is based in the US, with occasional travel.
What you need
Basic Qualifications
RPMs typically require a blend of regulatory knowledge and project management expertise. Desired skills include:
- Bachelor’s degree in a scientific or related field
- 8+ years of industry based regulatory experience
- Strong understanding of regulatory frameworks and compliance requirements in relevant industries
- Proficiency in project management tools (e.g., Microsoft Project, Smartsheet) and methodologies (PMP, PRINCE2, RAC) for planning, tracking, and reporting
- Excellent interpersonal and communication skills to engage stakeholders, facilitate meetings, and drive decision-making
- Communication skills are crucial for interacting with regulatory bodies, internal management, and cross-functional teams, facilitating collaboration and maintaining project alignment
- Analytical and problem-solving abilities to interpret regulatory requirements and translate them into actionable project tasks
- Attention to detail is important for preparing accurate documentation and maintaining regulatory compliance
What you'll do
- ·Project Planning and Execution: Develop and maintain integrated project plans for regulatory submissions (e.g., IND, NDA, BLA, MAA) and post-approval activities, ensuring adherence to scope, timelines, budgets, and quality standard
- Cross-Functional Coordination: Act as the primary regulatory contact for timelines from functions including Clinical, Nonclinical, CMC, Quality, and Commercial, fostering collaboration and alignment
- Risk Management: Identify, assess, and mitigate project risks, creating contingency plans to maintain compliance and meet milestones
- Regulatory Communication: Coordinate with Regulatory Strategy Lead to manage interactions with global health authorities, prepare teams for agency meetings, and lead responses to regulatory queries
- Documentation Oversight: Coordinate the authoring, review, and assembly of submission-ready regulatory dossiers, ensuring accuracy and consistency
- Budget and Resource Management: Develop and track project budgets, forecast expenditures, and report financial performance to leadership
Pay and benefits
$140,000 – $200,000 a year
Employer providedThe annual base salary range for this position is $140,000.00 to $200,000.00. 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
Generous 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 28% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in Massachusetts27 roles publishing pay
Director roles in the US101 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $140,000 | — | $200,000 |
| Massachusetts (middle half) | $207,500 | $232,500 | $264,500 |
| All US (middle half) | $209,500 | $235,000 | $264,000 |
This role: Centessa Pharmaceuticals (UK)'s own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Centessa Pharmaceuticals (UK)'s own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership9
- Regulatory submissions5
- GMP and compliance4
- Documentation and SOPs4
- Lab testing and methods2
- 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.
- 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
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany 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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Associate Director, Regulatory Project Management at Centessa Pharmaceuticals (UK)
Open until filled. $140K–$200K a year, employer provided.