Principal Regulatory Affairs Specialist, UK
Core
Lead global regulatory strategies and coordinate submissions for Phase 1-4 clinical trials across the PPD clinical research portfolio.
Role type
Principal Regulatory Affairs Specialist (Clinical Trials)
Builds
Global regulatory submissions (CTA) and strategic regulatory intelligence for clinical trial services.
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Global clinical trial regulatory strategy, CTA preparation and assembly, sponsor interaction, clinical trial document review, scientific literature assessment, project team management, bid defense meeting leadership, ICH guidelines expertise, global/regional/national regulatory requirements knowledge.
Preferred skills
Advanced degree, 8+ years experience, local language proficiency.
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Lead discussions and coordinate regulatory strategies globally for assigned clinical trials, act as liaison with internal and external clients, arrange and lead client and regulatory agency meetings, support business development initiatives, participate in launch and project team meetings.
Seniority
Principal, strategic leadership & mentorship