Regulatory Affairs Manager
Core
Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization, owning regulatory decision-making for assigned clinical programs.
Role type
Senior Regulatory Affairs Manager (Clinical)
Builds
Global regulatory strategies and submissions to Regulatory Authorities and Ethics Committees
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory strategy development, Cross-functional leadership, Regulatory submissions management, Project budgeting and forecasting, Client interface management, Risk identification and resolution
Preferred skills
Platform Protocols and Integrated Protocol Designs experience, Medical terminology and statistical concepts knowledge, Advanced expertise in clinical/preclinical/CMC/publishing disciplines
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Own regulatory decision-making for assigned clinical trials and programs, Lead the development and execution of global regulatory strategies, Drive the cross-functional clinical trial team to execute the agreed regulatory strategy, Manage project budgets and forecasting activities, Provide senior review and strategic advice for regional regulatory submissions
Seniority
Senior, hands-on IC with leadership responsibilities