Director of Regulatory Affairs
Recursion is a digital biology company industrializing drug discovery. Our approach is changing the game and pioneering a new future in our industry. We are working to solve some of the hardest, most meaningful problems facing human health today. Would you like to help us lead the Revolution?
The Impact You’ll Make
We are looking to get multiple programs—in a variety of therapeutic areas—into the clinic in the next few years; this kind of ambition requires innovation and a true ability to think about development in a new light. You will oversee both the strategic and tactical domains of our regulatory operations. In addition, you will perform due diligence activities on in-licensing opportunities and provide regulatory subject matter expertise as we outlicense programs. If you are looking for autonomy and the opportunity to build a regulatory affairs function from the ground up, let’s talk.
- Identify an optimal regulatory strategy for assigned projects, and then lead teams in examining regulatory strategy options
- Interface with regulatory authorities and outside consultants and supervise and provide guidance to other regulatory personnel
- Write, review, and edit regulatory documentation, ensuring it is fit for purpose, and serve as a resource for regulatory document authors regarding the appropriate content of submissions
The Team You’ll Join
As Director of Regulatory Affairs, you will be an essential member of the Recursion Development Team reporting to the SVP, Translational Medicine. The Development Team is an empowered, execution-minded group of business development and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities.
The Experience You’ll Need
- Bachelor’s degree in a relevant life science field. Advanced degree desirable
- Minimum 10 years progressive Regulatory Affairs experience
- 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) in eCTD format
- Ability to create and manage detailed timelines and/or experience with tracking regulatory activities across disciplines and territories
- Deep experience interacting with global health authorities
- Regulatory operations and publishing experience
- Experience in Quality Assurance and Compliance appreciated
- Confidence to understand the big picture, and recognize creative solutions that are fit-for-purpose for unique and unprecedented clinical programs is a must.
The Benefits/Perks You’ll Enjoy
- 100% Coverage of health, vision, and dental insurance premiums
- 401(k) with generous matching (immediate vesting)
- Stock option grants
- Two one-week paid company closures (summer and winter)
- Unlimited vacation/sick leave
- Onsite daycare facility
- Commuter benefit and vehicle parking to ease your commute
- Complimentary chef-prepared lunches and well-stocked snack bars
- Generous paid parental leave (including adoptive)
- Fully-paid gym membership to Metro Fitness, located just feet away from our new headquarters
- One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking
More About Us
Recursion is a digital biology company industrializing drug discovery. Recursion does this by combining automation, artificial intelligence, machine learning, in vivo validation capabilities and a highly cross-functional team to discover novel medicines that expand our collective understanding of biology. Recursion’s rich, relatable database of over 4 petabytes of biological images generated in-house on the company’s robotics platform enables advanced machine learning approaches to reveal drug candidates, mechanisms of action, novel chemistry, and potential toxicity, with the eventual goal of decoding biology and advancing new therapeutics that radically improve people’s lives. Recursion is proudly headquartered in Salt Lake City.
Check out what it is like to work at Recursion here!
Recursion is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. Recursion strictly prohibits and does not tolerate discrimination against applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex, pregnancy, gender (including gender nonconformity and status as a transgender individual), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, or any other characteristic protected under applicable federal, state, or local law.