Associate Director, Regulatory Operations and Intelligence
Recursion
5 hours ago
Remote
United States
$175,400 - $206,400 USD yearly
Operations
Associate/Director, Regulatory Operations and Intelligence
Responsibilities:
- Support global regulatory submissions by overseeing submission processes, managing regulatory documentation, and gathering regulatory intelligence to track regulatory trends.
- Collaborate with Regulatory Leads to develop submission/content plans for global regions (US, UK, EU), including planning, review, publishing, and timelines (e.g., pre-submissions, INDs/CTAs); may author administrative submission documents.
- Perform critical reviews of submission documents for consistency, quality, and completeness; identify gaps and make technical/grammatical edits as needed.
- Format and publish regulatory documents at the document level per health authority requirements and relevant style guide; conduct final reviews to ensure consistency/compliance, apply metadata, and archive finals post-publishing.
- Lead and interpret global regulatory developments to support strategic decisions for program expansions; provide clear, succinct summaries of regulatory requirements and implications for business and strategy.
- Maintain accurate and complete regulatory records/documentation in controlled systems; update interactive ongoing trackers regularly.
- Develop and enhance tools/processes for collecting, managing, and disseminating regulatory intelligence (e.g., InfoDesk, PinkSheets, Cortellis).
- Oversee regulatory systems data migration activities (analysis, planning, validation, and execution).
- Stay current on local/global regulatory submission requirements and implement new publishing requirements.
- Provide end-user training and administrative support for regulatory publishing systems; develop/deliver training for authors of source documents.
Qualifications:
- Master’s or Bachelor’s degree (BS/BA) in a scientific discipline preferred (equivalent work experience considered).
- 7+ years of industry experience in a regulatory publishing function.
- 5+ years experience with specialized regulatory submission and publishing systems (e.g., Lorenzo).
- Must have experience setting up regulatory intelligence functions and tools.
- FDA drug submission experience, including FDA electronic submission gateway and templates (EMA/MHRA portals preferred).
- Knowledge of CTD/eCTD structure/content/application processes; hands-on experience creating and submitting CTD/eCTD dossiers.
- Preferred: experience interacting with health authorities for operational systems.
- Preferred/Plus: technical writing (training materials, user guides, templates, SOPs).
- Ability to build strong relationships with vendors and cross-functional teams; critical thinking and strong attention to detail.
- Proficient with document/publishing/submission/tracking tools (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
- Plus: project management experience.
Responsibilities:
- Support global regulatory submissions by overseeing submission processes, managing regulatory documentation, and gathering regulatory intelligence to track regulatory trends.
- Collaborate with Regulatory Leads to develop submission/content plans for global regions (US, UK, EU), including planning, review, publishing, and timelines (e.g., pre-submissions, INDs/CTAs); may author administrative submission documents.
- Perform critical reviews of submission documents for consistency, quality, and completeness; identify gaps and make technical/grammatical edits as needed.
- Format and publish regulatory documents at the document level per health authority requirements and relevant style guide; conduct final reviews to ensure consistency/compliance, apply metadata, and archive finals post-publishing.
- Lead and interpret global regulatory developments to support strategic decisions for program expansions; provide clear, succinct summaries of regulatory requirements and implications for business and strategy.
- Maintain accurate and complete regulatory records/documentation in controlled systems; update interactive ongoing trackers regularly.
- Develop and enhance tools/processes for collecting, managing, and disseminating regulatory intelligence (e.g., InfoDesk, PinkSheets, Cortellis).
- Oversee regulatory systems data migration activities (analysis, planning, validation, and execution).
- Stay current on local/global regulatory submission requirements and implement new publishing requirements.
- Provide end-user training and administrative support for regulatory publishing systems; develop/deliver training for authors of source documents.
Qualifications:
- Master’s or Bachelor’s degree (BS/BA) in a scientific discipline preferred (equivalent work experience considered).
- 7+ years of industry experience in a regulatory publishing function.
- 5+ years experience with specialized regulatory submission and publishing systems (e.g., Lorenzo).
- Must have experience setting up regulatory intelligence functions and tools.
- FDA drug submission experience, including FDA electronic submission gateway and templates (EMA/MHRA portals preferred).
- Knowledge of CTD/eCTD structure/content/application processes; hands-on experience creating and submitting CTD/eCTD dossiers.
- Preferred: experience interacting with health authorities for operational systems.
- Preferred/Plus: technical writing (training materials, user guides, templates, SOPs).
- Ability to build strong relationships with vendors and cross-functional teams; critical thinking and strong attention to detail.
- Proficient with document/publishing/submission/tracking tools (e.g., MS Office, StartingPoint Templates, Adobe Acrobat, VEEVA Vault RIM).
- Plus: project management experience.