Regulatory Affairs Manager
Core
Managing drug licensing applications and maintaining regulatory compliance for pharmaceutical products in Switzerland.
Role type
Regulatory Affairs Manager
Builds
Drug licensing applications and regulatory submissions for Swissmedic
Domain
Healthcare / Pharmaceuticals
Deliverable
client delivery
Required skills
Drug licensing application preparation, Swissmedic regulatory compliance, label and artwork management, cross-functional collaboration, document management systems, regulatory information management systems, change control management
Preferred skills
Knowledge of additional local languages
Technologies
eCTD, docuBridge, Documentum, Veeva, TrackWise
Responsibilities
Create and submit drug licensing applications, manage existing licenses for all regulatory matters, serve as primary contact for Swissmedic, collaborate with Medical, Quality, and Commercial functions, participate in cross-functional projects locally, regionally, or globally
