Regulatory Affairs Manager

🏢 AmerisourceBergen · all AmerisourceBergen jobs
📍 Poland
📅 Posted 2026-07-22 · via Himalayas
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Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details 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 with a focus on Human medicinal products, while also - Veterinary medicinal products - Medical devices - Cosmetics - Food supplements - Herbal products can be in scope. Primary focus is Polish regulatory requirements - Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance activities - Communicate directly withclientsandPolish Health Authorities - Supportscientific advice proceduresand represent clients in interactions with health authorities in Poland - Plan and execute client projects in accordance with establishedKPIs - Provide regulatory consultancy to colleagues and clients onregulatory strategyandprocedure management - Monitor and applyregulatory intelligence, sharing relevant updates and insights across the team - Comply with, maintain, and improve internal regulatory and operational processes including creation of SOPs and working instructions, as required - Coordinate regulatory quality documentation, controlled records, and submission-support materials for assigned products, processes, or client engagements - Reviewchange controls, deviations, quality events, and related records to identify regulatory impact and support compliant disposition - Support the preparation, maintenance, and update offilings, registrations, certifications, and post-approval changes - Maintainaudit-ready tracking tools, documentation logs, and status 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 - 3+ years of experience in regulatory affairs for marketing

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