About the job
Recursion Pharmaceuticals seeks an Associate Director of Regulatory Operations and Intelligence based in New York, New York. This position manages global regulatory submissions and ensures regulatory intelligence stays current. The role oversees submission workflows, documentation, and the systems supporting Regulatory Affairs.
Key Responsibilities
- Collaboration: Partner with Regulatory Leads to design and implement submission and content strategies for regions such as the US, UK, and EU. Responsibilities include planning, reviewing, publishing, and tracking timelines for submissions like pre-submissions and INDs/CTAs. May contribute to drafting administrative documents, reviewing for accuracy and consistency, identifying documentation gaps, and making technical or grammatical edits.
- Document Management: Format and publish regulatory documents in line with health authority standards and style guides. Complete final reviews before publishing to ensure compliance, assign correct metadata, and archive materials after publication.
- Leadership: Independently monitor and analyze global regulatory developments. Summarize requirements and assess business impact to guide strategic decisions for program growth.
- Record Maintenance: Maintain accurate and complete regulatory records within controlled systems. Update interactive trackers regularly.
- Tool Development: Drive enhancements to tools and processes for gathering, managing, and distributing regulatory intelligence, utilizing platforms such as InfoDesk, PinkSheets, and Cortellis.
- Data Migration: Oversee data migration projects for new or existing Regulatory Affairs systems, including analysis, planning, validation, and execution.
