Regulatory Affairs Manager

MWI Animal Health; Town of Poland (NY); On-site; USD 68,508 - 102,762; Full time

Job summary

AmerisourceBergen recrute un Responsable Affaires Réglementaires pour la Pologne afin de diriger les activités de conformité et les soumissions. Vous gérerez les projets clients, coordonnerez les équipes et assurerez une interaction fluide avec les autorités polonaises.

Le poste exige une expertise en affaires réglementaires, une connaissance approfondie des exigences polonaises et des compétences en gestion de projets et relation client.

Qualifications

• Diplôme requis ou équivalent en sciences de la vie ou domaine pertinent.
• Exigence linguistique: polonais langue maternelle et anglais professionnel.

Responsibilities

• Développer et maintenir des relations solides avec les clients et identifier les opportunités d'expansion des services.
• Diriger les activités réglementaires pour obtenir et maintenir les autorisations de mise sur le marché pour les produits humains et vétérinaires, dispositifs médicaux, cosmétiques, compléments alimentaires et produits à base de plantes, avec un accent sur la Pologne.
• Préparer et examiner les documents réglementaires pour les soumissions, renouvellements et variations.
• Communiquer directement avec les clients et les autorités sanitaires polonaises.
• Planifier et exécuter les projets client selon les KPI.
• Coordonner les équipes de projet internes et externes.

Skills

Regulatory affairs

Project management

Client relationship management

Regulatory strategy

Documentation control

Analytical thinking

Communication skills

Education

Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field

Tools

Veeva Vault

Job description

## Regulatory Affairs ManagerPostulerlocations: NCEE > Poland > Remotetime type: Temps Pleinposted on: Publié aujourd'huijob requisition id: R2612110Cherchez-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**# ## Regulatory Affairs Manager - Poland**Advance regulatory success in the Polish market while leading high-value client projects across a diverse healthcare portfolio.**We are seeking an experienced and client-focused **Regulatory Affairs Manager - Poland** to support regulatory strategy, submissions, lifecycle management, and authority interactions for products regulated in Poland. This is a strong opportunity for a regulatory professional who combines deep local market knowledge with project leadership, client relationship management, and a practical, solutions-oriented approach.In this role, you will support projects involving human and veterinary medicinal products, as well as selected adjacent product categories such as medical devices, cosmetics, food supplements, and herbal products, helping clients navigate Polish regulatory requirements with confidence and efficiency.## ## About the Role:The Regulatory Affairs Manager - Poland is responsible for managing regulatory activities and client projects focused on Polish market requirements. The role includes maintaining and securing marketing authorizations, leading submission and lifecycle management activities, communicating with health authorities, advising on regulatory strategy, and coordinating project execution in line with agreed timelines and KPIs.This position is ideal for a professional who can build trusted client relationships, provide high-quality regulatory consultancy, coordinate project teams, and contribute to operational excellence across the broader function.## What You’ll Do:* Develop and maintain strong client relationships and identify opportunities for expanded service support* Participate in and lead regulatory activities to obtain and maintain marketing authorizations for: + Human medicinal products + Veterinary medicinal products + Medical devices + Cosmetics + Food supplements + Herbal products with a primary focus on Poland and Polish regulatory requirements* Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance activities* Communicate directly with clients and Polish Health Authorities* Support scientific advice procedures and represent clients in interactions with health authorities in Poland* Plan and execute client projects in accordance with established KPIs* Coordinate project teams across internal colleagues and qualified external partners* Provide regulatory consultancy to colleagues and clients on regulatory strategy and procedure management* Monitor and apply regulatory intelligence, sharing relevant updates and insights across the team* Present seminars and lectures for colleagues, clients, and professional audiences* Support department strategy implementation and continuous process optimization* Comply with, maintain, and improve internal regulatory and operational processes* Coordinate regulatory quality documentation, controlled records, and submission-support materials for assigned products, processes, or client engagements* Review change controls, deviations, quality events, and related records to identify regulatory impact and support compliant disposition* Support the preparation, maintenance, and update of filings, registrations, certifications, and post-approval changes* Analyze regulations, standards, and internal procedures to identify gaps, escalate atypical issues, and recommend practical next steps* Maintain audit-ready tracking tools, documentation logs, and staus reporting.**What We’re Looking For:*** Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.* Language Requirement: Polish (Native level) and English (Business conversational) - Essential* 2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required.* Proven experience in regulatory affairs or a related field requiring strong technical and practical regulatory knowledge* Strong hands-on experience managing new submissions and lifecycle management activities for medicinal products in Poland* Experience with adjacent product categories such as medical devices, cosmetics, food supplements, or herbal products is an advantage* Strong knowledge of Polish regulatory requirements and procedures* Ability to implement tactical goals across customer and internal projects* Proven ability to manage parallel priorities, identify risks, and take action to keep projects on track* Structured, analytical, systematic, and independent working style* Strong problem-solving ability with a pragmatic and service-oriented mindset* Experience supporting junior colleagues and coordinating smaller project teams* Strong relationship management skills across both day-to-day operational contacts and client leadership* Excellent written and verbal communication skills, including the ability to present issues and recommendations clearly to decision-makers* Strong presentation skills and a confident, professional presence* Experience with Veeva Vault is appreciated## Why Join UsThis is an opportunity to take on a visible and impactful role in a dynamic consulting environment, where your expertise in Polish regulatory affairs will directly support client success. You will work across a broad range of regulatory projects, contribute strategic insight, and help clients navigate complex requirements in a changing healthcare landscape.For professionals seeking a role that combines regulatory depth, project ownership, and client partnership, this position offers meaningful scope and growth.## Ideal CandidateYou are a proactive and dependable regulatory leader who enjoys combining technical expertise with strong client service. You are comfortable managing complex submissions, advising on regulatory pathways, coordinating stakeholders, and ensuring high-quality execution across multiple priorities. You bring sound judgment, strong organizational skills, and a collaborative approach to solving regulatory challenges.## ## Apply NowIf you are ready to bring your expertise in Polish regulatory affairs to a collaborative and growing environment, we encourage you to apply.Certification in regulatory affairs, quality management, compliance, auditing preferred.**Ce qu’Cencora offre** Nous offrons une rémunération globale concurrentielle. Notre engagement envers nos associés comprend l’offre de programmes d’avantages sociaux complets, diversifiés et conçus pour répondre aux divers besoins de l’ensemble de nos associés. Grâce à notre présence mondiale et nos diverses unités commerciales, nous avons une approche équilibrée des avantages que nous offrons. De nombreux avantages sociaux sont payés par l’entreprise, tandis que d’autres sont offerts par les cotisations des associés. Les offres d’avantages sociaux spécifiques peuvent varier selon l’emplacement, le poste ou l’unité d’affaires.Temps Plein