Manager of Regulatory Operations

Location
Salt Lake City, Utah
Posted
May 04, 2021
Ref
3112303
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.

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 grants
  • 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

 

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.

 

 

WE EMBRACE ALL CANDIDATES.  At Recursion, we care about creating a diverse environment to support innovation and to deliver on our mission of developing impactful medicines for patients.  We are committed to bringing together all minds, backgrounds and experiences and in cultivating an inclusive environment in which employees can thrive, learn and grow together.  To that end, we are an equal opportunity employer and we comply with all applicable federal, state and local fair employment practices laws.  We strictly prohibit and do not tolerate discrimination against applicants based on race, color, national origin, religion, creed, age, sex, sexual orientation, pregnancy, gender, gender identity or expression, physical or mental disabilities or differences, neurodiversity, genetic disposition, veteran status, or any other protected category under federal, state or local law.  We work to recognize and remove bias in recruiting, employing, developing, retaining and investing in our employees from all backgrounds and we feel that diverse voices are critical to our success.  This is how we act as One Recursion.

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.