Associate Director, CMC Regulatory Affairs

The Impact Youll 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 Recursions 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 investigators 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 Youll Join

As Manager/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 Recursions innovative science to patients through clinical and business development activities.

The Experience Youll 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 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 EU and other Ex-US submission experience is required.
• Excellent verbal and written communication skills

Working Location & Compensation:

Making London or Oxford (Milton Park) your home base is ideal; however we will consider remote work for this position. We ask that remote employees commit to regular on-site visits for routine work and departmental events.

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

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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 isnt about rushing but about moving the needle every day.
• We take ownership and accountability. Through ownership and accountability we enable trust and autonomyleaders 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.

Recursions 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 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.