Senior Specialist of Regulatory Operations

Your work will change lives. Including your own. 

The Impact You’ll Make

Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking a Senior Specialist, Regulatory Operations who will play a critical role in supporting global regulatory submissions, overseeing processes, and managing regulatory documentation. Additionally, this role involves managing regulatory submission and publishing systems used in Regulatory Affairs.

• Collaborate with Regulatory Leads to support the development of submission/content plans (planning, reviewing, publishing, and timelines - e.g., pre-submissions, INDs/CTAs) to global regions (e.g., US, UK, EU). May contribute to the authoring of administrative submission documents. Perform critical reviews of documents for consistency and quality, identifying gaps in supporting documentation, and making technical/grammatical edits as necessary .
• Format and publish regulatory documents at the document level in accordance with health authority requirements and appropriate style guide. Conduct a final review of pre-published submissions to ensure consistency and compliance with regulatory requirements, as well as proper metadata application and archive finals post publishing.
• Ensure that regulatory records and documentation are adequately maintained (e.g., accurate and complete) in controlled systems. The interactive on-going trackers should be updated regularly.
• Contribute to the development of new internal processes (SOPs, checklists, templates) for preparing submissions and managing regulatory records. Identify and implement opportunities for improving regulatory publishing and documentation systems.
• Oversee data migration activities related to new or existing systems in Regulatory Affairs, including analysis, planning, validation, and execution.
• Stay updated on local and global regulatory submission requirements and implement new publishing requirements.
• Support regulatory systems through end-user training and provide administrative support for preparing regulatory submissions in regulatory publishing systems. Develop and deliver training for authors of source documents.

Location:

Remote or Hybrid; We ask that remote employees commit to regular (at least once per quarter) on-site visits for routine work and departmental events.

The Team You’ll Join

Reporting to the Vice President, Regulatory, you’ll lead the regulatory operations and publishing function within the Regulatory Department. As the regulatory operations and publishing representative on this diverse team, you’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, and clinical development to support clinical programs (IND-enabling and clinical-stage assets) in alignment with Recursion’s regulatory strategy.

The Experience You’ll Need

• Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
• 5+ years of industry-related experience in a regulatory publishing function.
• 2+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo), including end-user support, training, and regulatory records and documentation management
• Experience in FDA regulatory submissions for drugs, including familiarity with the use of FDA's electronic submission gateway and templates. Experience with EMA/MHRA portals is a plus.
• Knowledge of regulatory requirements related to the structure, content, and application processes for regulatory submissions, particularly in CTD/eCTD format; hands-on experience with the successful creation and submission of CTD/eCTD dossiers.
• Experience interacting with health authorities for operational systems is preferred.
• Experience with technical writing (e.g., training materials, user guides, templates, SOPs) is a plus.
• Ability to establish excellent working relationships with vendors and internal cross-functional team members through consistent demonstration of integrity, credibility, reliability, and trust.
• Critical thinker with excellent attention to detail.
• Proficient use of software and tools for document formatting, publishing, submissions, and tracking (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
• Experience in project management is a plus.

How You’ll be Supported

• Participation in project-based meetings provide opportunities to integrate up front
• Regular 1:1s with supervisor and colleagues provide opportunities for support and feedback
• Training on Recursion’s culture and values and our Drug Discovery & Development processes to provide insight to our unique approach and strategy for success

At Recursion, we believe that every employee should be compensated fairly. Based on the skill and level of experience required for this role, the estimated current annual base range for this role is:

• Developing: $117,500 
• Skilled: $130,000
• Expert: $143,,000

To learn more about our level within levels, click here.

You will also be eligible for bonuses and equity compensation + our comprehensive benefits package for United States based candidates. The range displayed on each job posting reflects target ranges for US new hire salaries and is determined by job, level, and market factors.  

During the interview selection process, you will connect with a Talent Acquisition Partner who will be your advocate and ally to ensure you receive the appropriate compensation that meets your needs for your skills, experience, and relevant education/training, while also reviewing our very competitive total rewards package.

#LI-CP1

The Values That We Hope You Share:

• We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
• We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
• We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover. 
• Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
• We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.

Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.

More About Recursion 

Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.

Recursion is headquartered in Salt Lake City, where it is a founding member of BioHive, the Utah life sciences industry collective. Recursion also has offices in London, Toronto, Montreal and the San Francisco Bay Area. Learn more at www.Recursion.com, or connect on X (formerly Twitter) and LinkedIn.

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. 

Recursion welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.