Senior CMC Regulatory Lead — Associate Director

Relay Therapeutics; Cambridge (MA); On-site; USD 143,000 - 233,000; Full time

Job summary

Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success.

You will manage complex IND/IMPD/NDAs, contribute to regulatory intelligence, and oversee responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance.

Qualifications

• Bachelor or advanced degree in Pharmaceutical Sciences, Chemistry or related fields.
• Minimum of 8-10+ years of relevant experience in regulatory-CMC and/or within CMC function (e.g. analytical, formulation and process development, QA, QC) in biotech/pharma with focus on small molecules and oral solids.
• Experience with authoring/review/providing CMC content for CMC/quality submissions including IND and IMPD development/maintenance.
• Knowledge of eCTD Modules and QOS requirements for INDs/IMPDs and NDAs/MAAs.
• Experience managing submissions in RIM Veeva or equivalent; document formatting/Quality Control compliant with eCTD templates/requirements.

Responsibilities

• Develop and lead regulatory CMC strategies for investigational, registration and post-approval programs.
• Develop and execute CMC global submission plans and timelines.
• Lead responses to CMC questions/RFIs from regulatory authorities.
• Define CMC content requirements for submissions and review for conformance.
• Coordinate with cross-functional teams and act as CMC liaison between CMC/PD, regulatory affairs and program management.
• Lead regulatory assessment on product compliance topics including change controls and GMP investigations.
• Communicate CMC strategies, issues and risks to cross-functional teams and management.
• Keep abreast of regulatory guidance and scientific developments relevant to projects.
• Demonstrate strong technical writing and document review skills.

Skills

CMC regulatory

Regulatory strategy

Global RA/CMC

Regulatory submissions

Communication

Education

Bachelor or advanced degree in Pharmaceutical Sciences/ Chemistry

Tools

Veeva/RIM

Job description

Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success.

You will manage complex IND/IMPD/NDAs, contribute to regulatory intelligence, and oversee responses to RFIs with minimal supervision, driving high-quality submissions and robust compliance.