Regulatory Affairs Manager (m/w/d)
Core
Managing national and European regulatory approval procedures (DCP, MRP, RUP) for pharmaceuticals, medical devices, supplements, and cosmetics.
Role type
Regulatory Affairs Manager
Builds
Regulatory dossiers (eCTD) and product launches for pharmaceutical and life sciences products
Domain
Life Sciences / Pharmaceuticals / Medical Devices
Required skills
European and German pharmaceutical regulations, DCP/MRP/RUP procedures, Lifecycle management, eCTD, regulatory compliance assessment, stakeholder communication
Preferred skills
Medical devices, supplements, and cosmetics regulations, Nordic country regulations, Nordic Packaging knowledge
Technologies
CESP, PharmNet.Bund, EMA-Systems
Responsibilities
Create, submit, and maintain national and European regulatory approval procedures; Handle variations, renewals, and license transfers; Create and maintain electronic regulatory dossiers (eCTD); Review product information and labeling for compliance; Support product launches and business development projects; Communicate with authorities and partners; Maintain regulatory databases.
Seniority
Mid-Senior, hands-on IC