Associate Director, Regulatory Operations and Intelligence

Recursion • Salt Lake City, UT

93d • $175,400 - $206,400

About The Position

We are seeking an Associate/Director, Regulatory Operations and Intelligence who will play a critical role in supporting global regulatory submissions, overseeing submission processes, managing regulatory documentation and gathering regulatory intel to keep programs and organization updated with latest regulatory trends. 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 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. Contribute to the development and enhancement of tools and processes used for collecting, managing, and disseminating regulatory intelligence (InfoDesk, PinkSheets, Cortellis, etc.) 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.

Requirements

• Master’s or Bachelor's degree (BS/BA) in a scientific discipline preferred.
• 7+ years of industry-related experience in a regulatory publishing function.
• 5+ years of experience with specialized regulatory submission and publishing systems.
• Experience with setting up regulatory intelligence functions and tools.
• Experience in FDA regulatory submissions for drugs.
• Familiarity with EMA/MHRA portals is a plus.
• Knowledge of regulatory requirements for regulatory submissions.
• Hands-on experience with CTD/eCTD dossiers.
• Experience interacting with health authorities for operational systems.
• Experience with technical writing is a plus.
• Ability to establish excellent working relationships with vendors and internal teams.
• Critical thinker with excellent attention to detail.
• Proficient in software for document formatting and publishing.
• Experience in project management is a plus.

Responsibilities

• Support global regulatory submissions and oversee submission processes.
• Manage regulatory documentation and gather regulatory intel.
• Collaborate with Regulatory Leads to develop submission/content plans.
• Contribute to the authoring of administrative submission documents.
• Perform critical reviews of documents for consistency and quality.
• Format and publish regulatory documents according to health authority requirements.
• Conduct final reviews of pre-published submissions for compliance.
• Lead, monitor, analyze, and interpret global regulatory developments.
• Deliver summaries on regulatory requirements and implications.
• Enhance tools and processes for managing regulatory intelligence.
• Maintain regulatory records and documentation in controlled systems.
• Develop new internal processes for preparing submissions.
• Oversee data migration activities in Regulatory Affairs.
• Stay updated on regulatory submission requirements.
• Support regulatory systems through end-user training.

Benefits

• Annual bonus and equity compensation.
• Comprehensive benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Master's degree
• Number of Employees: 501-1,000 employees