Regulatory Affairs Manager

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🕒 4 days ago

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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. • Manage regulatory activities and client projects focused on Polish market requirements. • Maintain and secure marketing authorizations, leading submission and lifecycle management activities. • Communicate with health authorities and advise on regulatory strategy. • Coordinate project execution in line with agreed timelines and KPIs. • 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. • Monitor and apply regulatory 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. • Review change controls, deviations, quality events, and related records to identify regulatory impact and support compliant disposition.

🎯 Requirements

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required. • 3+ years of experience in regulatory affairs for marketing authorizations in Poland. • 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. • Additional experience in regulatory activities in the EU is welcomed. • 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. • 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.

🏖️ 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.