Manager, Regulatory Operations
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
- Create, manage and execute regulatory content plans to support regulatory submissions
- Plan and oversee timelines, document finalization, processes and vendors for regulatory submissions
- Review, format and edit regulatory documents and serve as a resource for document authors regarding formatting, finalization and sign off content
- Manage relationships with diverse internal and external stakeholders
The Team You’ll Join
The Development Team is an empowered, execution-minded group of clinical development professionals responsible for translating Recursion's innovative science to patients through clinical activities. As a Manager, Regulatory Operations, you will initially report to the Senior Director of Clinical Operations. In your role, you will work with colleagues in Development across the Recursion organization to manage regulatory submissions, which includes planning, compiling, publishing, delivering and archiving of regulatory submissions.
The Experience You’ll Need
- BS/BA in life sciences
- Minimum 5+ years regulatory operations experience in a biopharmaceutical company
- Experience preparing and maintaining multiple ongoing submissions, content plans, timelines, tracking of documents, monitoring vendors, status of submission components and archiving finalized and submitted documents.
- Solid knowledge of US FDA and EU EMA electronic publishing requirements as well as the regulatory requirements with regard to technical and formatting aspects of global regulatory submission publishing
- Experience in communicating complex issues, observations and resolutions to management
- Experience identifying potential risks and mitigations associated with regulatory operations to stakeholders
- Experience in time management and effective organization skills to meet challenging deadlines
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
**US based employees
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.
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.