FSP Regulatory Affairs Principle Specialist - Regulatory Liaison client dedicated
Core
Serve as the primary regulatory interface for clinical trial teams, ensuring compliance with global and local regulations and facilitating timely submissions.
Role type
Senior Regulatory Liaison (Clinical Trials)
Builds
Regulatory submission packages (CTAs, amendments, IBs, IMPDs) for clinical trials
Domain
Healthcare / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
EU Clinical Trial Regulation (CTR) expertise, regulatory submission management, project management, analytical skills, documentation tracking, process improvement
Preferred skills
FDA/EU MDR/IVDR/ICH knowledge, team leadership, quality management systems (GMP), additional languages
Technologies
Regulatory submission systems, document management tools
Responsibilities
Represent Regulatory Affairs at Clinical Trial Teams, prepare and coordinate regulatory submission packages, monitor delegated activities, liaise with Transparency Leads, contribute to process improvements, collaborate with Regulatory Scientists and Coordinators
Seniority
Senior, hands-on IC with leadership exposure
