Director, CMC Regulatory Strategist

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life.

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 Manager/Director CMC Regulatory Strategist 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

• BA/BS, MS or PhD in relevant technical discipline; RAC certification preferred, 5+ years’ experience in CMC regulatory (both drug product and drug substance).
• Understanding of US regulations, strategic advice, and supporting leaders in navigating regulatory requirements and implementing change. EU and Ex-US experience is a plus. 
• Demonstration of cross-functional understanding and technical team support related to CMC aspects of drug development.
• Demonstrated track record of authoring and producing high quality INDs, IND amendments, NDAs, meeting packages and achieving timelines.  EU and Ex-US submission experience is a plus.
• Excellent verbal and written communication skills

#LI-CP1

The Benefits/Perks You’ll Enjoy as a Full-Time Employee at Recursion: 

• 100% Coverage of health, vision, and dental insurance premiums 
• 401(k) with generous matching (immediate vesting)
• Stock option, restricted stock unit (RSUs) and employee stock purchase plan (ESPP) programs
• Two one-week paid company closures (summer and winter) 
• Flexible vacation/sick leave
• Generous paid parental leave (including adoptive)
• Onsite daycare facility** (Salt Lake City)
• Commuter benefit and vehicle parking to ease your commute** 
• Complimentary chef-prepared lunches and well-stocked snack bars** (Salt Lake City)
• Monthly fitness/wellness stipend 
• One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking** (Salt Lake City)

**United States based employees

More About Us 

Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City. 

Learn more at www.recursion.com, or connect on Twitter and LinkedIn.

Recursion is an Equal Opportunity Employer that values diversity and inclusion.  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.