Principal Regulatory Affairs Specialist
Core
Lead regulatory affairs specialist providing strategic intelligence and guidance for clinical trial authorization, licensing, and lifecycle management from preclinical stages through registration.
Role type
Principal Regulatory Affairs Specialist (Clinical Trials)
Builds
Regulatory submissions and compliant deliverables for pharmaceutical and biotech clients
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory strategy, ICH guidelines, clinical trial authorization, lifecycle management, project management, budgeting/forecasting, medical terminology, statistical concepts, negotiation, editorial/proofreading
Preferred skills
Local language proficiency, matrix leadership, business development
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Review regulatory documents and submissions, provide strategic advice on projects of moderate complexity, participate in project management, mentor junior team members, ensure adherence to SOPs and budgets, contribute to business development
Seniority
Principal, hands-on IC with mentorship
