Senior Manager, EU Hub

Senior Manager, EU Hub - regulatory lifecycle strategy and hub delivery leadership for European markets, including post-approval maintenance activities, cross-functional collaboration, and team leadership.

Responsibilities

Develop and execute regulatory execution strategies for lifecycle maintenance activities across European (EU and non-EU) countries within a Hub operating model; Lead end-to-end coordination of post-approval maintenance activities including variations, renewals, notifications/administrative changes, labeling/PI updates, post-approval commitments, line extensions, and country-specific maintenance requirements; Translate global strategy into country action plans defining scope, timelines, dependencies, stakeholders, and deliverables; Anticipate regulatory and operational risks and propose mitigation plans; Coordinate preparation, review, and submission readiness of required documentation ensuring alignment with core dossiers and company standards; Lead responses coordination to regulatory authority questions, deficiency letters, and compliance requests for assigned markets; Coordinate EU PI/labeling updates and drive alignment/harmonization with local labels; Monitor and apply evolving requirements and trends in EU and non-EU European markets; Ensure lifecycle activities are executed in compliance with applicable regulations, internal SOPs, and quality systems; Contribute to continuous improvement by standardizing ways of working; Partner with Global and Local functions to secure inputs, manage dependencies, and drive decisions; Act as the primary Hub interface for local RA teams for assigned countries/products; Run effective cross-functional/cross-country governance; Provide execution leadership within the Hub team; Coach and mentor junior colleagues; Drive a proactive culture

Requirements

University degree in Life Sciences, Pharmacy, Medicine, or related field; 8–15+ years of regulatory affairs experience in the pharmaceutical industry with strong focus on European markets and post-approval/lifecycle maintenance; Demonstrated hands-on experience with EU procedures (CP/DCP/MRP/national) and practical understanding of how lifecycle actions are executed across EU and non-EU European countries; Proven track record coordinating multi-country, multi-product portfolios with tight timelines and complex cross-functional dependencies; Experience coordinating responses to Health Authority requests (questions/deficiencies) and driving input collection and closure; Comfortable working with regulatory information/document systems (e.g., Veeva Vault RIM or equivalent), trackers, and structured portfolio reporting; Strong execution leadership in high-volume, multi-country lifecycle maintenance environments; Proactiveness and ownership mindset; Excellent communication (written and verbal); Ability to prioritize under pressure and manage competing timelines across products/countries with disciplined tracking; Strong stakeholder management and influencing skills across geographies and functions; Structured, process-oriented approach with continuous improvement mindset; Team leadership and talent development mindset

Nice to have

Hub/shared services experience