Participate actively in registration/labeling activities, including review and validation of translations for SmPC, Package Leaflet, and Labeling in relation to the parent company
Job Summary
Participate actively in registration/labeling activities, including review and validation of translations for SmPC, Package Leaflet, and Labeling in relation to the parent company.
Contribute to regulatory intelligence at national, European, and international levels by coordinating local regulatory intelligence.
Amgen offers a diverse and inclusive community where team members have the opportunity to contribute ideas and take action.
Matching Summary
Participate actively in registration/labeling activities, including review and validation of translations for SmPC, Package Leaflet, and Labeling in relation to the parent company.
Skills & Requirements
Must-have
Regulatory intelligence
Clinical trial submissions
Promotional material evaluation
Labeling review and validation
English language proficiency
Nice-to-have
Proactive communication skills
Strong synthesis abilities
Team collaboration and expertise sharing
Key Requirements
Bac+6 alternance in Pharmacy with specialization in Regulatory Affairs or Health Law