Regulatory Affairs Manager
Core
Manage regulatory submissions to obtain and maintain marketing approvals for medical devices and pharmaceutical products, design RA strategy, and lead cross-functional meetings.
Role type
Senior Regulatory Affairs Manager
Builds
Regulatory submissions and product registrations for medical devices and pharmaceuticals
Domain
Healthcare (Medical Devices & Pharmaceuticals)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory submission management, product registration, deficiency letter response, government agency liaison, labeling compliance, registration planning, project management, team leadership, regulatory change impact assessment, SOP development
Preferred skills
New drug application (NDA) experience, clinical drug development knowledge, early pipeline product management
Technologies
Regulatory submission systems, compliance tracking tools
Responsibilities
Manage registration of new products and variations, coordinate responses to deficiency letters, liaise with government agencies, update product labeling, generate registration plans, lead cross-functional meetings, manage team performance, streamline RA processes
Seniority
Senior, hands-on IC with team leadership
