Senior RA Specialist
Core
Senior Regulatory Affairs Specialist providing strategic regulatory intelligence and guidance for product development from preclinical stages through registration and optimization for pharmaceutical and biotech clients.
Role type
Senior IC regulatory affairs specialist
Builds
Regulatory submissions, project-specific processes, compliant deliverables
Domain
Pharmaceutical/Biotech industry, Global/Regional/National regulatory affairs
Deliverable
client delivery
Required skills
Regulatory strategy, regulatory submissions preparation, contract scope identification, cross-functional liaison, training and guidance, project budgeting/forecasting, global/regional/national regulatory requirements knowledge, ICH guidelines knowledge, medical terminology, statistical concepts
Preferred skills
None explicitly stated
Technologies
Microsoft Word, Excel, PowerPoint
Responsibilities
Prepare and review regulatory submissions; Provide regulatory strategy and technical advice to clients; Lead development of project-specific processes; Collaborate with departments, consultants, and authorities; Identify out-of-scope contract activities; Provide training to junior members; Participate in project launch and review meetings; Support business development and budgeting.
Seniority
Senior, hands-on IC