Associate Director, Regulatory Starting Material
Centessa Pharmaceuticals
August 20, 2026
On-site
Boston, MA
Operations
Key Responsibilities:
- Lead identification, justification, and regulatory strategy for Regulatory Starting Materials (RSM) across drug substance synthetic routes per ICH Q11 and relevant regional guidance.
- Manage starting material resupply campaigns and scale-up efforts (inventory, forecasts, manufacturing timing, suite slot reservations, contracting).
- Author/review CMC regulatory submission content for RSM selection/justification (e.g., Module 3, briefing documents, agency responses) supporting INDs/NDAs/MAAs.
- Prepare and lead health authority interactions (e.g., Type C meetings, scientific advice), including briefing packages and agency representation.
- Partner with Process Chemistry and Analytical Development to evaluate routes, assess structural relevance, and support impurity fate-and-purge and risk assessments for RSM designation.
- Define/document the non-GMP vs GMP boundary for drug substance manufacturing steps with CMOs and internal quality standards.
- Lead technology transfer and process changes impacting RSM designation as programs progress to commercial manufacturing.
- Manage relationships with drug substance/API CMOs and RSM suppliers (technical oversight, site visits, supplier qualification, dual-sourcing).
- Monitor global regulatory guidance/precedent and update internal strategy/templates/risk assessments.
- Collaborate cross-functionally to support timelines, submission readiness, and commercial supply continuity.
- Support due diligence (licensing/partnering) assessments.
- Provide subject matter expertise during regulatory inspections and audits.
- Build, lead, and mentor an RSM/CMC strategy team.
- Travel ~10–20%.
Qualifications:
- PhD strongly preferred; advanced degree in chemistry/chemical engineering or related field.
- 8–10 years relevant experience in CMC, process chemistry, and/or drug substance/API development/manufacturing; leadership of starting material or CMC regulatory strategy.
- Experience supporting late-stage clinical and/or commercial drug substance programs.
- Deep working knowledge of ICH Q11 and applicable regional guidance.
- Experience authoring/defending CMC submission content and leading/participating in health authority interactions.
- Strong synthetic/process chemistry background; ability to evaluate route scouting, impurity control, and structural relevance arguments.
- Experience managing CMOs/suppliers (batch record reviews and manufacturing oversight).
- Working knowledge of cGMP and GMP/non-GMP boundary.
- Technology transfer experience preferred.
- Strong leadership, cross-functional collaboration, and scientific writing/communication; sound judgment.
- Ability to identify/address starting material risks to protect regulatory timelines and supply.
Benefits/Compensation:
- Annual base salary range: $140,000–$210,000.
- Discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, health and wellness program.
- Lead identification, justification, and regulatory strategy for Regulatory Starting Materials (RSM) across drug substance synthetic routes per ICH Q11 and relevant regional guidance.
- Manage starting material resupply campaigns and scale-up efforts (inventory, forecasts, manufacturing timing, suite slot reservations, contracting).
- Author/review CMC regulatory submission content for RSM selection/justification (e.g., Module 3, briefing documents, agency responses) supporting INDs/NDAs/MAAs.
- Prepare and lead health authority interactions (e.g., Type C meetings, scientific advice), including briefing packages and agency representation.
- Partner with Process Chemistry and Analytical Development to evaluate routes, assess structural relevance, and support impurity fate-and-purge and risk assessments for RSM designation.
- Define/document the non-GMP vs GMP boundary for drug substance manufacturing steps with CMOs and internal quality standards.
- Lead technology transfer and process changes impacting RSM designation as programs progress to commercial manufacturing.
- Manage relationships with drug substance/API CMOs and RSM suppliers (technical oversight, site visits, supplier qualification, dual-sourcing).
- Monitor global regulatory guidance/precedent and update internal strategy/templates/risk assessments.
- Collaborate cross-functionally to support timelines, submission readiness, and commercial supply continuity.
- Support due diligence (licensing/partnering) assessments.
- Provide subject matter expertise during regulatory inspections and audits.
- Build, lead, and mentor an RSM/CMC strategy team.
- Travel ~10–20%.
Qualifications:
- PhD strongly preferred; advanced degree in chemistry/chemical engineering or related field.
- 8–10 years relevant experience in CMC, process chemistry, and/or drug substance/API development/manufacturing; leadership of starting material or CMC regulatory strategy.
- Experience supporting late-stage clinical and/or commercial drug substance programs.
- Deep working knowledge of ICH Q11 and applicable regional guidance.
- Experience authoring/defending CMC submission content and leading/participating in health authority interactions.
- Strong synthetic/process chemistry background; ability to evaluate route scouting, impurity control, and structural relevance arguments.
- Experience managing CMOs/suppliers (batch record reviews and manufacturing oversight).
- Working knowledge of cGMP and GMP/non-GMP boundary.
- Technology transfer experience preferred.
- Strong leadership, cross-functional collaboration, and scientific writing/communication; sound judgment.
- Ability to identify/address starting material risks to protect regulatory timelines and supply.
Benefits/Compensation:
- Annual base salary range: $140,000–$210,000.
- Discretionary annual bonus; 401(k), medical/dental/vision/life insurance, paid time off, health and wellness program.