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.

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