Director, CMC Regulatory Affairs

Recursionpharmaceuticals•5h ago

United KingdomRemote£111.1K–£141.8KFull-timeDirector Level8+ yrs exp

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Top focus

Regulatory Affairs

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
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
qualifications needed for this role, the estimated annual base salary range is: £111,100—£141,800 . In addition to base salary, this role is eligible for an annual bonus, equity compensation
a comprehensive benefits package.
#LI-REMOTE
#LI-ES1
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
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
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
clinical development into a unified intelligence system. Powered by proprietary multimodal data, purpose-built AI models
bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter — faster, better
at scale — for patients who are waiting.
Recursion’s platform infrastructure is anchored in Salt Lake City, Utah and Milton Park, Oxfordshire
its automated biology and chemistry laboratories generate proprietary data at industrial scale. Recursion also maintains offices in New York, Montréal
London, three global hubs for talent and leadership at the intersection of AI and scientific innovation. Learn more at www.recursion.com
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
any other characteristic protected under applicable federal, state, local
provincial human rights legislation.
Accommodations are available on request for candidates taking part in all aspects of the selection process.
Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion
Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.

Required skills

CMC regulatorydrug developmentGMPINDNDAclinical trialsrisk managementregulatory strategycross-functional collaboration