Remote CMC Regulatory Director: Global Submissions

Menlo Ventures; New York (NY); On-site; USD 228,250 - 280,720; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Benefits package

Job summary

Recursion is seeking a Director of CMC Regulatory Affairs to lead the global CMC regulatory strategy for Phase 1–3 programs. You will oversee development, coordination of regulatory submissions across US, EU, and ROW, and guide cross-functional teams on drug substance and product requirements.

Ideal candidates have 8+ years in CMC regulatory, strong technical knowledge, and experience authoring INDs, NDAs, and comprehensive submission packages.

Qualifications

• 8+ years’ experience in CMC regulatory (drug product and drug substance).
• Deep technical knowledge of small molecule drug development and regulatory standards.
• Experience guiding US, EU and ROW submissions and lifecycle management.
• Excellent verbal and written communication skills.

Responsibilities

• Lead development and implementation of CMC regulatory strategy for global trials and filings.
• Influence regulatory strategy across programs and provide guidance on CMC submissions.
• Strategize, write, manage contributors and review region-specific CMC documents.
• Deliver high-quality US, EU and ROW submissions and regulatory advice.
• Support review of labels, protocols and trial materials; participate in GMP inspections as needed.
• Assess risk and implement mitigation for GMP regulations across regions.

Skills

CMC regulatory strategy

Regulatory submissions

Cross-functional collaboration

GMP/regulatory knowledge

IND drafting/NDAs

Excellent communication

Education

BA/BS, MS or PhD in relevant discipline

RAC certification preferred

Job description

Recursion is seeking a Director of CMC Regulatory Affairs to lead the global CMC regulatory strategy for Phase 1–3 programs. You will oversee development, coordination of regulatory submissions across US, EU, and ROW, and guide cross-functional teams on drug substance and product requirements.

Ideal candidates have 8+ years in CMC regulatory, strong technical knowledge, and experience authoring INDs, NDAs, and comprehensive submission packages.