Senior Manager, EU Hub

MWI Buying Group; Dadri; On-site; INR 2,500,000 - 6,000,000; Full time

Job summary

AmerisourceBergen recherche un Senior Manager, EU Hub pour diriger les activités réglementaires et la coordination multi-pays depuis Noida (Inde). Vous superviserez les stratégies de lifecycle, gérerez les interactions avec les autorités et assurerez la conformité tout en optimisant les livrables du hub.

Le candidat idéal possède 8–15+ années dans les affaires réglementaires pharmaceutiques, une expérience EU et une aptitude à coordonner des portefeuilles multi-produits dans des délais serrés.

Qualifications

• Gestion du cycle réglementaire et leadership de hub.
• Développement et exécution de stratégies de mise en œuvre réglementaire pour le cycle de vie.
• Coordination transfrontalalière multi-pays et multi-produits sous contraintes temporelles.
• Réponses aux demandes des autorités et suivi des documents.
• Conception et amélioration des templates, trackers et processus de hub.

Responsibilities

• Fournir un leadership d’exécution dans un environnement à fort volume et multi-pays.
• Gérer les dépendances et les livrables en collaboration avec des fonctions globales et locales.
• Assurer que les activités du cycle de vie respectent les régulations et SOP internes.
• Mentorer et coacher les collègues sur les priorités et les communications.
• Établir et suivre les risques et escalades procèdent.

Skills

Execution leadership

Proactive ownership

Communication

Stakeholder management

Prioritization

Education

University degree in Life Sciences, Pharmacy, Medicine, or related field

Tools

Veeva Vault RIM

Job description

## Senior Manager, EU HubPostulerlocations: APAC > India > Noidatime type: Temps Pleinposted on: Publié aujourd'huijob requisition id: R265772Cherchez-vous à faire une différence dans la vie d’un patient? Chez AmerisourceBergen, vous trouverez une culture innovante et collaborative, axée sur le patient et soucieuse de faire la différence. En tant qu’organisation nous sommes unis par notre responsabilité d’œuvrer pour des vies plus saines. Joignez-vous à nous et postulez dès aujourd’hui!# **Ce que vous ferez**# **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.