Regulatory Affairs Manager

Job not on LinkedIn

🕒 July 15

🇵🇱 Poland – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 30%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Cencora

WebsiteLinkedInAll Job Openings

10,000+ employees

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

Cencora is a company dedicated to improving the health and well-being of both people and animals globally. Built on the legacy of AmerisourceBergen, Cencora offers a wide range of industry-leading solutions that encompass specialty logistics, warehousing, drug research, clinical development support, and more. They provide commercialization and patient access support and offer wholesale and specialty distribution services. Cencora serves a diverse clientele, including pharmaceutical companies, physician practices, pharmacies, and health systems. The company also extends its services to animal health, managing operations and delivering products for animal pharmaceutical care. With a strong global footprint, Cencora aims to reshape healthcare delivery through innovative products and solutions, striving to create healthier futures for all.

📋 Description

• Advance regulatory success in the Polish market while leading high-value client projects across a diverse healthcare portfolio. • Support regulatory strategy, submissions, lifecycle management, and authority interactions for products regulated in Poland. • Maintain and secure marketing authorizations, leading submission and lifecycle management activities. • Communicate with health authorities, advising on regulatory strategy. • Coordinate project execution in line with agreed timelines and KPIs. • Develop and maintain strong client relationships and identify opportunities for expanded service support. • Prepare, review, and compile regulatory documentation for submissions, renewals, variations, and lifecycle maintenance activities. • Support scientific advice procedures and represent clients in interactions with health authorities in Poland. • Plan and execute client projects in accordance with established KPIs. • 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.

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required. • 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

• 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.