Director, CMC Regulatory Affairs

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

Your work will change lives. Including your own.

The Impact You’ll Make

• Lead development and implementation of CMC regulatory strategy for small molecule investigational drugs in global Phase 1-3 clinical trials and marketing applications.
• Influence the regulatory strategy of Recursion’s development programs by attending team meetings, providing drug substance or drug product recommendations for US, EU and Rest of World (ROW) regulatory requirements/guidance interpretation, and best practices for CMC submissions and meetings.
• Strategize, plan, write, manage internal and external contributors and review region specific investigational stage CMC summary submission documents (Module 2, Module 3, IMPD, etc.) and agency requests.
• Deliver high quality regulatory US, EU and ROW submissions, strategy and advice.
• Support review of investigational product labels, protocols, investigator’s brochure, and other clinical trial materials; GMP inspections as needed.
• Assess and identify on an ongoing basis, risk mitigation plans based on current and changing US and Ex-US GMP regulations and guidance.

The Team You’ll Join

As Director CMC Regulatory Affairs, you will be an essential member of the Recursion Development Team, reporting to the Vice President of Regulatory Affairs. The Development Team is an empowered, execution-minded group of development, manufacturing and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities.

The Experience You’ll Need

• 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 (both drug product and drug substance).
• Extensive command of worldwide CMC regulatory standards and directives for facilitating clinical research, securing international trial approvals, and life-cycle management
• Understanding of US and ex-US regulations, providing strategic advice, and supporting cross functional teams in navigating regulatory requirements and implementing change. US, EU and other Ex- US experience is required.
• 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 of drug development.
• Managing multiple projects and priorities
• Demonstrated track record of authoring and producing high quality INDs, IND amendments, NDAs, meeting packages and achieving timelines. US, EU and other Ex-US submission experience is required.
• Excellent verbal and written communication skills

Working Location & Compensation:

This role is remote-friendly, with most work conducted from home. There may be occasional opportunities or expectations for travel to our Salt Lake City headquarters or other office locations.

At Recursion, we believe that every employee should be compensated fairly. Based on the skills, experience, and qualifications needed for this role, the estimated annual base salary range is:

• Salt Lake City & all other U.S. locations: $207,500–$255,200

In addition to base salary, this role is eligible for an annual bonus, equity compensation, and a comprehensive benefits package.

The Values We Hope You Share:

• We act boldly with integrity. We are unconstrained in our thinking, take calculated risks, and push boundaries, but never at the expense of ethics, science, or trust.
• We care deeply and engage directly. Caring means holding a deep sense of responsibility and respect - showing up, speaking honestly, and taking action.
• We learn actively and adapt rapidly. Progress comes from doing. We experiment, test, and refine, embracing iteration over perfection.
• We move with urgency because patients are waiting. Speed isn’t about rushing but about moving the needle every day.
• We take ownership and accountability. Through ownership and accountability, we enable trust and autonomy—leaders take accountability for decisive action, and teams own outcomes together.
• We are One Recursion. True cross‑functional collaboration is about trust, clarity, humility, and impact. Through sharing, we can be greater than the sum of our individual capabilities.

Our values underpin the employee experience at Recursion. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.

More About Recursion

Recursion (NASDAQ: RXRX) is a clinical‑stage TechBio company decoding biology to radically improve lives. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need. Enabling its mission is the Recursion OS, an AI‑native, end‑to‑end drug discovery and development platform integrating biology, chemistry, and clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose‑built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better, and at scale — for patients who are waiting. Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire, where its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal, and London, three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com, or connect on X and LinkedIn.

Recursion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.

Accommodations are available on request for candidates taking part in all aspects of the selection process.