Regulatory Affairs Manager/Senior Manager-EU Hubra Job Profile - Title to be Assigned

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Job Details

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.
  
  

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.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex India Private Limited

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 company’s 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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned