1.
IND and NDA Submission Management
• Lead or support authoring, assembly, quality review, and submission management for IND Module 1 content and other U.S. administrative submission components.
• Maintain detailed tables of contents and submission trackers to provide visibility to content ownership, status, dependencies, approvals, and publishing readiness.
• Coordinate with regulatory publishing, document management, asset management, and subject matter experts to deliver complete, accurate, and timely submission packages.
• Draft and coordinate FDA forms, cover letters, submission metadata, and supporting administrative documentation.
• Manage review and approval workflows, resolve content or formatting gaps, and oversee handoffs through established publishing and submission processes.
• Support major regulatory submissions, including INDs, NDAs, supplements, amendments, and related health authority correspondence.
2.
Health Authority Meeting and Correspondence Support
• Author and coordinate health authority meeting requests, briefing documents, meeting packages, and associated administrative components.
• Establish timelines, coordinate subject matter expert input, track reviews, and support finalization and submission.
• Coordinate FDA information request responses by engaging appropriate subject matter experts, consolidating content, and managing review cycles and timelines.
• Archive health authority correspondence and meeting records with accurate indexing, version control, and traceability.
• Ensure actions, commitments, and follow-up activities are documented and routed to the appropriate stakeholders.
3.
IND and NDA Lifecycle Maintenance
• Prepare and coordinate IND and NDA lifecycle submissions, including protocol amendments, investigator updates, CMC amendments, Investigator’s Brochure updates, annual reports, supplements, and other regulatory maintenance activities.
• Author or coordinate applicable regulatory content for PADERs, PBRERs/PSURs, DSURs, Investigator’s Brochures, and other periodic or safety-related reports with cross-functional contributors.
• Prepare, review, and coordinate NDA Annual Reports and other required post-approval submissions.
• Maintain visibility to commitments, reporting obligations, submission deadlines, and lifecycle deliverables.
4.
Regulatory Intelligence and Strategic Support
• Conduct targeted regulatory intelligence searches to identify relevant health authority guidelines, policies, and regulatory precedents.
• Synthesize findings into clear, decision-oriented slide decks to guide upcoming regulatory activities and strategic discussions.
• Highlight implications, comparable precedents, potential considerations, and information gaps for regulatory leadership and program teams as requested to support regulatory strategy materials for program, governance, and alliance discussions.
5.
Global Regulatory Team and Cross-Functional Coordination
• Prepare high-quality slide decks for monthly or quarterly Global Regulatory Team meetings, governance discussions, and alliance meetings, based on each program’s cadence.
• Coordinate agenda content, consolidate functional updates, track decisions and actions, and help keep deliverables aligned with program milestones.
• Participate in Global Regulatory Team, clinical trial team, and partner or alliance meetings as a Regulatory Affairs representative.
• Collaborate with Clinical, CMC, Nonclinical, Safety, Quality, Commercial, Regulatory Operations, Publishing, and Asset Management colleagues.
6.
Regulatory Documentation, Systems and Compliance
• Maintain U.S. regulatory archive logs, record new submissions, and file health authority correspondence and partner documentation promptly and accurately.
• Upload and manage correspondence and regulatory records received from global partners.
• Ensure proper indexing, metadata, version control, and traceability using RIM, EDMS, and other applicable tools.
• Maintain complete, inspection-ready records aligned with internal procedures and regulatory expectations.
• Maintain Form FDA 1572 waiver and clinical documentation trackers; author waiver requests and support related submissions, as needed.
• Conduct regulatory reviews of study start-up documentation, as assigned, to support IND-level compliance.