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Associate Director of Regulatory Operations and Intelligence

Recursion PharmaceuticalsNew York, New York
On-site Full-time $176.4K/yr - $240.8K/yr

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Experience Level

Senior Level Manager

Qualifications

Qualifications:Advanced degree in a relevant field (PhD, Master's, or equivalent experience preferred). Significant experience in regulatory affairs, operations, or intelligence, preferably in the pharmaceutical or biotechnology industry. Strong understanding of global regulatory submission processes and requirements. Excellent organizational, analytical, and problem-solving skills. Proficient in managing regulatory documentation and compliance. Exceptional communication and interpersonal skills to effectively collaborate across teams. Experience with regulatory submission and publishing systems is highly desirable.

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.

About Recursion Pharmaceuticals

Recursion Pharmaceuticals is a pioneering pharmaceutical company leveraging advanced technology to accelerate drug discovery and development. Our mission is to transform the lives of patients through innovative therapies and a commitment to excellence in scientific research.

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