Regulatory Affairs Manager

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.

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.

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, and 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

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 authorizations in Poland, additional background in quality assurance, compliance, documentation control, or a related field is appreciated

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

Experience with Veeva Vault is appreciated

Why Join Us

This is an opportunity to take on a visible and impactful role in a dynamic consulting environment, where your expertise in Polish regulatory affairs will directly support client success. You will work across a broad range of regulatory projects, contribute strategic insight, and help clients navigate complex requirements in a changing healthcare landscape.

For professionals seeking a role that combines regulatory depth, project ownership, and client partnership, this position offers meaningful scope and growth.

Ideal Candidate

You are a proactive and dependable regulatory leader who enjoys combining technical expertise with strong client service. You are comfortable managing complex submissions, advising on regulatory pathways, coordinating stakeholders, and ensuring high-quality execution across multiple priorities. You bring sound judgment, strong organizational skills, and a collaborative approach to solving regulatory challenges.

Apply Now

If you are ready to bring your expertise in Polish regulatory affairs to a collaborative and growing environment, we encourage you to apply.

Certification in regulatory affairs, quality management, compliance, auditing preferred.