Senior Manager, EU Hub
Core
Lead end-to-end coordination of post-approval maintenance activities (variations, renewals, labeling updates) across European markets within a Hub operating model.
Role type
Senior Manager, Regulatory Lifecycle Strategy & Hub Delivery
Builds
Regulatory lifecycle maintenance deliverables for pharmaceutical products across EU and non-EU European countries
Domain
Pharmaceutical industry, Regulatory Affairs, European Markets
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory lifecycle strategy, multi-country coordination, risk anticipation, compliance planning, cross-functional collaboration, team leadership, stakeholder management, process standardization
Preferred skills
Hub/shared services experience, experience with Veeva Vault RIM or equivalent systems
Technologies
Veeva Vault RIM, CTD/eCTD, trackers
Responsibilities
Develop and execute regulatory execution strategies for lifecycle maintenance; translate global strategy into country action plans; coordinate responses to regulatory authority questions and deficiency letters; monitor evolving regulatory requirements and communicate impacts; coach and mentor junior colleagues; drive alignment and harmonization of EU PI/labeling updates
Seniority
Senior Manager, strategic execution & team leadership
