Associate Director, Regulatory Starting Material

Socket.dev; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Centessa Pharmaceuticals seeks an Associate Director, Regulatory Starting Material to lead strategy and justification for RSM in drug substance manufacturing, aligning with ICH Q11 and global guidance. You will partner with Process Chemistry, Analytical Development, and Regulatory Affairs to defend RSM strategies through health authority interactions and regulatory submissions.

The role requires 8–10 years in CMC or drug substance development, strong leadership, and a track record of regulatory

Qualifications

• 8-10 years of relevant experience in CMC, process chemistry or drug substance/API development/manufacturing
• Demonstrated leadership of starting material or CMC regulatory strategy programs
• Experience supporting late-stage clinical and/or commercial drug substance programs
• Deep working knowledge of ICH Q11 and regional guidance governing RSM selection
• Experience authoring and defending CMC regulatory submission content and health authority interactions
• Strong background in synthetic/process chemistry and route evaluation

Responsibilities

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials
• Manage resupply campaigns, inventory, forecasting, and scheduling
• Author and review CMC regulatory submission content for INDs/NDAs/MAAs
• Lead health authority interactions and prepare briefing packages
• Collaborate with Process Chemistry and Analytical Development on routes and impurity risk
• Define GMP/non-GMP boundary for drug substance processes and CMOs
• Lead tech transfer and process changes affecting RSM designation
• Oversee relationships with CMOs and raw material suppliers
• Monitor evolving regulatory guidance and update internal templates
• Collaborate with Regulatory Affairs, Quality, Supply Chain, and Manufacturing to ensure readiness and continuity
• Support due diligence and regulatory inspections/audits
• Build, lead, and mentor RSM/CMC strategy team
• Travel approximately 10–20%

Skills

Regulatory strategy

Cross-functional collaboration

Scientific writing

Leadership

Risk assessment

Health authority interactions

Project management

CMC regulatory submissions

Education

Advanced degree in chemistry, chemical engineering, or related field

PhD strongly preferred

Job description

Description of Role

Centessa is currently seeking an Associate Director, Regulatory Starting Material. This individual 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.

Key Responsibilities

• 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%).

Qualifications

• 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.

Compensation

The annual base salary range for the Associate Director 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.

Work Location

The (Associate) Director, Regulatory Starting Material 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.

Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.