Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
At Recursion, we combine experimental biology, automation, and artificial intelligence to quickly and efficiently identify treatments for human diseases. The Director of Regulatory Affairs is responsible for setting the regulatory strategy and the management of regulatory aspects of the company’s development projects.
THE PROBLEMS YOU’LL SOLVE
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, focus, and a true ability to think about development in a new light. The position reports to the SVP of Strategic Development, and 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 out-license programs. If you are looking for autonomy and the opportunity to build a regulatory affairs function from the ground up, let’s talk.
In this role you will:
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 PERKS YOU’LL ENJOY
Coverage of health, vision, and dental insurance premiums (in most cases 100%)
401(k) with generous matching (immediate vesting)
Stock option grants
Two one-week paid company closures (summer and winter) in addition to flexible, generous vacation/sick leave
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
New 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking
WHAT WE DO
We start with various human cell types in our automated laboratory, where we perturb biology 100,000 different ways each week (e.g. model a disease of interest, add a chemical compound, or some combination of those). We image the resulting cells using high throughput microscopy, resulting in about 2 million new images (or greater than 20 terabytes of data) each week. These data are analyzed using computer vision and machine learning methods that help us measure how cell morphology changes in subtle ways in each biological context. We can answer direct questions (e.g. are there compounds that rescues a disease-specific set of morphological changes), and over time as our dataset has increased, we can ask more complex questions across biology.
From the outset, our approach is agnostic to preconceived notions and dogma in biology, enabling Recursion to operate in novel target space. In order to move the discovery and development process more quickly and with higher confidence, we are expanding this platform to enable us to use our image-based dataset to make predictions about biological pathways, mechanism and how each potential therapeutic will perform in later IND-enabling studies, including ADME, Tox, etc. We are also evaluating what additional high-dimensional biological datasets could extend our predictive capacity with the aim to extend our predictive capabilities and further accelerate drug discovery and development.
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.
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
Employer will assist with relocation costs.
Additional Salary Information: Highly competitive salary with industry leading benefits.
Internal Number: 1
About Recursion Pharma
Recursion Pharmaceuticals is an emerging biotechnology company that combines experimental biology, automation, and artificial intelligence in a massively parallel system to quickly and efficiently identify treatments for any disease which can be modeled at the cellular level. Recursion’s platform has been used to identify potential new treatments for genetic, inflammatory and oncological diseases, and is being applied broadly in additional areas of biology including infectious disease and diseases of aging. Founded in 2013, Recursion’s tech-first approach will enable treatments for diseases in a fraction of the typical timeframe and at a fraction of the cost and ultimately lead the company in building a roadmap of human cellular biology.