Responsibilities

Regulatory Lifecycle Strategy & Hub Delivery Leadership

• Develop and executeregulatory execution strategiesforlifecycle maintenanceactivities across European (EU and nonEU) countries within aHub operating model maximizing Hub-delivered work and minimizing local execution where feasible.

• Lead end-to-end coordination ofpost-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 intocountry 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 toregulatory authority questions deficiency letters and compliance requestsfor assigned markets ensuring timely input collection quality review and on-time dispatch.

• CoordinateEU PI / labeling updatesand 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 nonEU 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 actionsespecially when stakeholders are in different time zones.

Leadership Accountability & Mentoring (Critical Success Factor)

• Provide execution leadership within the Hub team: demonstratehigh ownership and accountabilityfor 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

• Strongexecution leadershipin high-volume multi-country lifecycle maintenance environments.

• Proactiveness and ownership mindset: anticipates issues drives closure and ensures accountability across stakeholders.

• Excellentcommunication(written and verbal): concise status updates clear escalation messages and strong meeting facilitation.

• Ability toprioritize under pressureand manage competing timelines across products/countries with disciplined tracking.

• Strongstakeholder management and influencing skillsacross 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).

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Qualifications & Experience

• University degree in Life Sciences Pharmacy Medicine or related field.

• 815 yearsof regulatory affairs experience in the pharmaceutical industry with strong focus onEuropean marketsandpost-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 nonEU European countries.

• Proven track record coordinatingmulti-country multi-productportfolios 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 RIMor equivalent) trackers and structured portfolio reporting.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned