RA Manager(Senior Manager)
Core
Provide strategic regulatory intelligence and guidance for pharmaceutical and biotech product development from preclinical stages through registration and optimization.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory submissions, project budgets, and client deliverables for pharmaceutical and biotech clients
Domain
Life Sciences / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, China regulatory submissions, project budgeting/forecasting, contract management, matrix leadership, ICH guidelines, clinical trial authorization, lifecycle management, medical terminology, statistical concepts
Preferred skills
Pricing strategy, proposal development, training junior staff, global/regional/national regulatory requirements
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Provide senior review and advice for China regulatory submissions; Act as subject matter expert for moderate to high complexity client projects; Manage project budgeting and forecasting; Identify out-of-scope contract activities; Collaborate on pricing and new business proposals; Provide matrix leadership and training to junior team members; Ensure compliance with organizational SOPs and WPDs
Seniority
Senior, hands-on IC with mentorship
