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 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

• 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

• 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

• 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

• Maintain audit-ready tracking tools, documentation logs, and status reporting