Regulatory Affairs Manager (Global Clinical Trial Applications)
Core
Lead preparation of global regulatory submissions for Clinical Trial Applications (CTA) and provide strategic regulatory intelligence for Phase 1–4 clinical trials.
Role type
Senior individual contributor Regulatory Affairs Manager
Builds
Global regulatory strategies and submissions for clinical trials
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Global/regional regulatory requirements knowledge, ICH guidelines expertise, project management, client-facing communication, budgeting and forecasting, contract modification management, proposal development, team leadership, SOP compliance
Preferred skills
Advanced degree, 9+ years experience
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Lead preparation of global regulatory submissions for CTA; Act as subject matter expert for regulatory strategy advice; Provide oversight across multiple studies/projects; Act as senior client-facing lead for regulatory planning and proposals; Manage project budgeting/forecasting; Collaborate with business development for pricing and new business; Provide matrix/project leadership to team members; Ensure compliance with organizational and regulatory SOPs.
Seniority
Senior, hands-on IC with oversight