Regulatory Strategy Lead, Drug Substance (RSM)

BioSpace; Indiana; On-site; USD 153,000 - 268,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation

Medical benefits

Flexible benefits

Life insurance

Well-being benefits

Job summary

Centessa is seeking a Senior Advisor, Regulatory Starting Material to lead strategy, justification, and regulatory positioning for Regulatory Starting Materials in drug substance manufacturing for late-stage clinical and commercial programs. Reporting to the Vice President, CMC, this role serves as SME on RSM selection across routes, ensuring GMP starting points are defensible and aligned with readiness.

You will collaborate with Process Chemistry, Analytical Development, Regulatory Affairs,

Qualifications

• Deep knowledge of ICH Q11 and regional guidance for starting materials.
• Experience authoring and defending CMC regulatory submissions and interacting with authorities.
• Strong background in synthetic/process chemistry with material-scale perspective.

Responsibilities

• Lead identification, justification, and regulatory strategy for Regulatory Starting Materials across routes.
• Manage starting material resupply and scale-up, including forecasting and scheduling.
• Author and review CMC content related to RSM for INDs/NDAs/MAAs.
• Lead health authority interactions and prepare briefing packages.
• Collaborate with Process Chemistry and Analytical Development to evaluate routes and impurity strategies.
• Define GMP/non-GMP boundaries for drug substance processes and oversee tech transfer.
• Manage CMOs and raw material suppliers with oversight and continuidad programs.
• Monitor regulatory guidance updates and translate to internal strategies.

Skills

CMC regulatory strategy

Regulatory submissions

Health authority meetings

Leadership & mentoring

ICH Q11 knowledge

Process Chemistry collaboration

Regulatory starting materials

GMP knowledge

Communication skills

Education

PhD strongly preferred

Advanced degree in chemistry or related field

Job description

Centessa is seeking a Senior Advisor, Regulatory Starting Material to lead strategy, justification, and regulatory positioning for Regulatory Starting Materials in drug substance manufacturing for late-stage clinical and commercial programs. Reporting to the Vice President, CMC, this role serves as SME on RSM selection across routes, ensuring GMP starting points are defensible and aligned with readiness.

You will collaborate with Process Chemistry, Analytical Development, Regulatory Affairs,