VP of Regulatory Affairs

Location
Salt Lake City, Utah
Posted
Jun 07, 2021
Ref
3127865
Required Education
Bachelors Degree
Position Type
Full time

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.

***Flexible work arrangements for those who are unable to relocate***

The Impact You’ll Make

  • Develop and oversee the execution of regulatory strategy, including responsibility for formal interactions and submissions. This includes leading company implementation of national and international regulatory guidelines and advice
  • Assure company compliance with regulatory guidelines and best practices
  • Provide strategic regulatory guidance with all internal and external stakeholders
  • Implement and oversee operational plans to achieve company regulatory objectives
  • Partner with and support clinical development, CMC, preclinical, quality, medical affairs, commercial and corporate activities, including the review and submission of clinical protocols and regulatory documents, publications, investor relations/legal public disclosures throughout the product life cycle
  • Responsible for being the primary regulatory agency contact (at the FDA and at other agencies)

The Team You’ll Join 

As VP of Regulatory Affairs, you will be an essential member of the Recursion Development Team reporting to the Chief Medical Officer. The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to patients through clinical development activities.

The Experience You’ll Need

  • Bachelor's degree in a relevant life science field required. Advanced degree (MS or Doctorate) preferred
  • Minimum 15 years progressive experience in medical device, biologics or pharmaceutical regulatory affairs environment
  • Experience complying with in-house regulatory specifications and FDA, EU and international regulations
  • Experience in clear communication, analytical and problem-solving skills.
  • Specialized knowledge that would be desirable and supportive of success in this position includes:
    • Experience in rare/ultra rare drug development
    • Experience in pediatric drug development and understanding of global regulations related to pediatric requirements
    • Understanding of regulatory requirements for and experience with submission of applications (IND / NDA)
    • Experience managing detailed timelines and experience with tracking regulatory activities with diverse teams and territories
    • Deep experience working with global health authorities
    • Regulatory operations and publishing experience

The Benefits/Perks You’ll Enjoy

  • 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*
  • Commuter benefit and vehicle parking to ease your commute* 
  • Complimentary chef-prepared lunches and well-stocked snack bars* 
  • 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*

*Subject to change for remote-based employees during the COVID-19 pandemic

 

More About Us 

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science, and engineering, with the goal of radically improving the lives of patients and industrializing drug discovery. 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. 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, or local law.