- Serve as the point of contact for Health Authorities.
- Translate regulatory strategy into interaction plans, submission plans, timelines, and cross-functional deliverables.
- Lead preparation, coordination, and delivery of INDs, IND amendments, annual reports, meeting requests, CTAs, and lifecycle submissions.
- Schedule and coordinate meeting rehearsals before Health Authority interactions.
- Finalize Health Authority meeting minutes, responses to information requests, and follow-up actions.
- Oversee submission publishing and delivery.
- Partner with cross-functional contributors to develop content, resolve data gaps, and maintain an aligned submission narrative.
- Maintain records of correspondence, commitments, decisions, and submission history.
- Establish and maintain regulatory plans, workflows, submission calendars, trackers, and archives.