Remote CMC Regulatory Director: Shape Global Trials

Segment (Twilio); New York (NY); On-site; USD 207,500 - 255,200; Full time

Benefits offered by this job

Remote-friendly

Job summary

Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW. You’ll coordinate internal and external contributors and drive region‑specific CMC documents (Module 2/3, IMPD) and decisive regulatory submissions.

This role emphasizes strategic leadership, fast‑paced timelines, and close collaboration with Regulatory Affairs leadership to advance clinical programs and lifecycle management.

Qualifications

• Deep technical knowledge of small molecule drug development.
• BA/BS, MS or PhD in relevant technical discipline; RAC certification preferred, 8+ years’ experience in CMC regulatory.
• Extensive command of worldwide CMC regulatory standards for clinical research and life-cycle management.
• Understanding of US and ex-US regulations, providing strategic advice, and supporting cross functional teams in navigating regulatory requirements.
• Assess and manage risks for drug development in all regions as applicable.
• Demonstration of cross-functional understanding and technical team support related to CMC aspects.

Responsibilities

• Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 trials and marketing applications.
• Influence the regulatory strategy of development programs by attending team meetings and advising on US, EU and ROW requirements.
• Strategize, plan, write, manage internal and external contributors and review region specific CMC documents (Module 2/Module 3, IMPD, etc.).
• Deliver high quality regulatory US, EU and ROW submissions, strategy and advice.
• Support review of investigational product labels, protocols, investigator’s brochure, and GMP inspections as needed.
• Assess and identify risk mitigation plans based on current and changing US and Ex-US GMP regulations and guidance.

Skills

CMC regulatory strategy

Regulatory affairs

Risk management

Project management

Cross-functional collaboration

IND/NDAs preparation

Education

BA/BS in relevant technical discipline

MS/PhD in relevant discipline

RAC certification

Job description

Recursion, a clinical‑stage TechBio company, seeks a Director CMC Regulatory Affairs to lead regulatory strategy for small molecule programs across US, EU and ROW. You’ll coordinate internal and external contributors and drive region‑specific CMC documents (Module 2/3, IMPD) and decisive regulatory submissions.

This role emphasizes strategic leadership, fast‑paced timelines, and close collaboration with Regulatory Affairs leadership to advance clinical programs and lifecycle management.