Senior Specialist, Regulatory Operations

Summary

Join a dynamic team at Recursion, where you'll play a critical role in supporting global regulatory submissions and overseeing processes as a Senior Specialist, Regulatory Operations.

Requirements

• Bachelor's degree (BS/BA) in a scientific discipline preferred; equivalent work experience will be considered
• 5+ years of industry-related experience in a regulatory publishing function
• 2+ years of experience working with specialized regulatory submission and publishing systems (e.g., Lorenzo), including end-user support, training, and regulatory records and documentation management
• 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 interacting with health authorities for operational systems is preferred
• 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)

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 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
• 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

Benefits

• Estimated current annual base range for this role is: Developing: $117,500 Skilled: $130,000 Expert: $143,000
• Bonuses and equity compensation + our comprehensive benefits package for United States based candidates