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 Trials)
Builds
Global regulatory strategies, submissions to Regulatory Authorities and Ethics Committees, and compliant clinical trial execution plans.
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy development, cross-functional leadership, submission preparation, risk management, stakeholder management, budget forecasting, ICH guidelines expertise, medical terminology, project management
Preferred skills
Platform Protocols experience, Integrated Protocol Designs, advanced expertise in clinical/preclinical/CMC/publishing disciplines
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Own regulatory decision-making for assigned clinical trials; translate indication-level strategy into actionable trial-level plans; lead cross-functional teams to execute regulatory strategies; prepare and review global regulatory submissions; manage project budgets and identify out-of-scope activities; coach and guide junior team members.
Seniority
Senior, hands-on IC with leadership responsibilities
