Principal Regulatory Affairs Specialist (Global Clinical Trial Applications)
Core
Lead global regulatory strategies and coordinate submissions for Phase 1-4 clinical trials across 100+ countries.
Role type
Principal Regulatory Affairs Specialist (Global Clinical Trial Applications)
Builds
Global regulatory submissions (CTA) and strategic regulatory intelligence for clinical research projects.
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Global clinical trial landscape knowledge, CTA preparation and assembly, sponsor interaction, clinical trial document review, scientific literature assessment, project team management, bid defense meeting experience, ICH guidelines expertise, country-specific regulatory requirements knowledge
Preferred skills
Advanced degree, leadership in global regulatory projects, bid defense meeting facilitation
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Prepare and assemble global regulatory submissions (CTA), interact with sponsors, review and assess clinical trial regulatory documents, review and assess scientific literature, manage project teams and preparation, participate in launch and review meetings, arrange and lead client and regulatory agency meetings
Seniority
Principal, strategic leadership & global coordination
