Associate Director, Regulatory Operations and Intelligence

• 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.
• Lead the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.)

This role plays a critical role in supporting global regulatory submissions and gathering regulatory intelligence to advance clinical programs, ultimately helping to decode biology to radically improve lives and advance the future of medicine.

• Master's or Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered.
• 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.

Estimated annual base range: $175,400 - $206,400 (USD). Eligible for an annual bonus and equity compensation, as well as a comprehensive benefits package. The organization values include acting boldly with integrity, caring deeply and engaging directly, learning actively and adapting rapidly, moving with urgency because patients are waiting, taking ownership and accountability, and being One Recursion through cross-functional collaboration.

Recursion is a clinical stage TechBio company leading the space by decoding biology to radically improve lives. The company leverages sophisticated machine-learning algorithms and massive experimental and computational scale to advance the future of medicine.