Cencora is a leading pharmaceutical solutions organization centered on improving the lives of people and animals everywhere. With 46,000+ global team members, we have the opportunity to make a positive impact on healthcare in communities everywhere. Our team members are empowered to activate their careers through a collective of tools and resources designed to support individual career interests and aspirations. We value our listening culture that actions real outcomes and our team members appreciate and recognize one another for contributions that are making a meaningful global impact. No matter what your role is here, the work we do together has meaning. When you join our team, you become a crucial part of a greater purpose. We’re committed to supporting you personally and professionally, so we can achieve more together at the center of health. Protect yourself from job scams: Recruitment scams are on the rise. To protect yourself, we urge you to be vigilant and follow these guidelines > https://careers.cencora.com/us/en/job-scams
Regulatory Affairs Manager
Location
Poland
Posted
23 hours ago
Salary
0
Seniority
Lead
Job Description
Regulatory Affairs Manager
Cencora
Role Description 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 - 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 - 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 status reporting Qualifications - 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 Benefits - Opportunity to take on a visible and impactful role in a dynamic consulting environment - Work across a broad range of regulatory projects - Contribute strategic insight and help clients navigate complex requirements - Meaningful scope and growth for professionals seeking a role that combines regulatory depth, project ownership, and client partnership 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.
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