Recursion · 2 weeks ago
Associate Director, Regulatory Operations and Intelligence
Salt Lake City, UT
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$175K/yr - $206K/yr
7+ years expRecursion is a clinical stage TechBio company focused on decoding biology to improve lives. They are seeking an Associate Director, Regulatory Operations and Intelligence to support global regulatory submissions, manage documentation, and gather regulatory intelligence to keep the organization updated with trends in the regulatory landscape.
Artificial Intelligence (AI)BiotechnologyMachine LearningPharmaceuticalSoftwareTherapeutics
Hiring Manager
Daniel Benavides
Responsibilities
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 the 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
Independently lead, monitor, analyze, and interpret global regulatory developments to ensure strategic decision-making for program expansions. Deliver succinct summaries on regulatory requirements and information that clearly communicates relevant implications, expectations, actions and potential impact to business, policies, process, and strategies
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
Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.)
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
Qualification
Required
7+ years of industry-related experience in a regulatory publishing function
5+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo)
Experience with setting up regulatory intelligence functions and tools is a must
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 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
Preferred
Master's or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered
Experience interacting with health authorities for operational systems is preferred
Benefits
Annual bonus
Equity compensation
Comprehensive benefits package
Company
Recursion
Recursion (NASDAQ: RXRX) is a clinical stage TechBio company leading the space by decoding biology to radically improve lives.
501-1000 employees
H1B Sponsorship
Recursion has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (6)
2023 (5)
2022 (2)
2021 (1)
Funding
Current Stage
Public CompanyTotal Funding
$865.38MKey Investors
NVIDIAKinnevikLeaps by Bayer
2024-06-26Post Ipo Equity· $200M
2023-07-12Post Ipo Equity· $50M
2022-10-25Post Ipo Equity· $150M
Leadership Team
Chris Gibson
Co-Founder and Chairman
Ben Mabey
Chief Technology Officer
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