Job Opportunities API

Unsere Teammitglieder sind das Herzstück unserer Arbeit. Bei Cencora sind wir vereint in unserer Verantwortung, eine gesündere Zukunft zu schaffen und jeder Mensch hier ist für uns unverzichtbar, um diesen Zweck zu erfüllen. Wenn du einen Unterschied im Zentrum der Gesundheit machen möchtest, komm und werde Teil unseres innovativen Unternehmens und hilf uns dabei, das Leben von Menschen und Tieren überall zu verbessern. Bewirb dich noch heute! Ihre Aufgaben Responsibilities • Regulatory Lifecycle Strategy & Hub Delivery Leadership • Develop and execute  regulatory execution strategies  for  lifecycle maintenance  activities across European (EU and non‑EU) countries within a  Hub operating model , maximizing Hub-delivered work and minimizing local execution where feasible. • Lead end-to-end coordination of  post-approval maintenance activities , including (as applicable)  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 : define scope, timelines, dependencies, stakeholders, and deliverables; maintain robust trackers and ensure “no-surprise” execution. • Anticipate regulatory and operational risks (e.g., missing inputs, data gaps, conflicting country expectations, dependency delays), propose mitigation plans, and support timely decision-making. • Coordinate preparation, review, and submission readiness of required documentation (e.g., Module 1 country components and relevant CTD/eCTD content as needed), ensuring alignment with core dossiers and company standards. • Lead responses coordination to  regulatory authority questions, deficiency letters, and compliance requests  for assigned markets, ensuring timely input collection, quality review, and on-time dispatch. • Coordinate  EU PI / labeling updates  and drive alignment/harmonization with local labels (where in scope), ensuring timely implementation and traceable decision logs. • Regulatory Compliance, Planning Discipline & Intelligence Application • Monitor and apply evolving requirements and trends in EU and non‑EU European markets; proactively communicate impacts to Hub and local stakeholders with clear recommended actions. • Ensure lifecycle activities are executed in compliance with applicable regulations, internal SOPs, and quality systems, maintaining inspection/audit readiness for assigned processes. • Contribute to continuous improvement by standardizing ways of working (templates, trackers, RACI, escalation paths, meeting cadence) to improve timeliness, predictability, and Hub share of work. • Cross Functional Collaboration & Country Coordination • Partner with Global and Local functions (e.g., Regulatory Ops, CMC, Pharmacovigilance, Medical, Quality, Supply Chain, Artwork/Labeling, Commercial as applicable) to secure inputs, manage dependencies, and drive decisions. • Act as the primary Hub interface for local RA teams for assigned countries/products: align on timelines, clarify responsibilities, proactively follow up, and escalate when required. • Run effective cross-functional/cross-country governance (action-focused meetings, minutes, owners, due dates) and ensure closure of actions—especially when stakeholders are in different time zones. • Leadership, Accountability & Mentoring (Critical Success Factor) • Provide execution leadership within the Hub team: demonstrate  high ownership and accountability  for outcomes (not just task assignment), ensuring activities are progressed, completed, and documented. • Coach and mentor junior colleagues on prioritization, stakeholder communication, escalation, and quality expectations; delegate tasks with clear outputs and follow-up checkpoints. • Drive a proactive culture: early risk identification, timely escalation with options and recommendations, and consistent communication discipline. . Key Competencies • Strong  execution leadership  in high-volume, multi-country lifecycle maintenance environments. • Proactiveness and ownership mindset : anticipates issues, drives closure, and ensures accountability across stakeholders. • Excellent  communication  (written and verbal): concise status updates, clear escalation messages, and strong meeting facilitation. • 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 (able to obtain inputs without direct authority). • Structured, process-oriented approach; continuous improvement mindset to increase Hub effectiveness and reduce local take-back. • Team leadership and talent development mindset (coaching, effective delegation with quality control). Qualifications & Experience • 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 (Hub/shared services experience strongly preferred). • 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. Was Cencora bietet Wir bieten eine wettbewerbsfähige, auf dem Total-Rewards-Ansatz basierende Vergütung. Unser Engagement für unsere Mitarbeiter umfasst Leistungsprogramme, die umfassend, vielfältig und so konzipiert sind, dass sie den verschiedenen Bedürfnissen unserer Belegschaft gerecht werden. An den unterschiedlichen Orten unserer weltweiten Präsenz und in den verschiedenen Geschäftseinheiten verfolgen wir ein ausgewogenes Konzept bezüglich der Leistungen, die wir anbieten. Viele Leistungen werden vom Unternehmen bezahlt, während andere durch Beiträge für Mitarbeiter verfügbar sind. Spezifische Leistungsangebote können je nach Standort, Position und/oder Geschäftseinheit variieren. Vollzeit Affiliated Companies Affiliated Companies: PharmaLex India Private Limited Chancengleichheit bei der Beschäftigung AmerisourceBergen verpflichtet sich, gleiche Beschäftigungschancen zu bieten, ohne Rücksicht auf Ethnie, Hautfarbe, Religion, Geschlecht, sexuelle Orientierung, Geschlechtsidentität, genetische Informationen, nationale Herkunft, Alter, Behinderung, Veteranenstatus oder Zugehörigkeit zu einer anderen durch Bundes-, Landes- oder Kommunalrecht geschützten Gruppe.