Regulatory Affairs Manager (Global Clinical Trial Applications)
Core
Lead global regulatory submissions for clinical trials (Phase 1–4) and provide strategic regulatory intelligence to internal and external clients.
Role type
Senior individual contributor Regulatory Affairs Manager
Builds
Global regulatory strategies and submission packages for clinical research projects
Domain
Clinical research / Regulatory Affairs / Life Sciences
Deliverable
client delivery
Required skills
Global/regional regulatory requirements knowledge, ICH guidelines expertise, project management, client-facing leadership, budgeting and forecasting, contract modification management, proposal and bid defense support, matrix leadership, SOP compliance
Preferred skills
Advanced degree, 9+ years of 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 and financial accountability; Collaborate with business development for pricing and new business; Provide matrix leadership to team members; Ensure compliance with organizational and regulatory SOPs
Seniority
Senior, hands-on IC with oversight across multiple projects