Manager Regulatory Affairs & Quality Assurance (CEE Region)

Pracovní nabídka

We are hiring for our client, a global biopharmaceutical company with a strong focus on rare diseases, innovation and patient safety.
To strengthen their regional Medical & Compliance capabilities, we are looking for an experienced Manager Regulatory Affairs & Quality Assurance who will oversee RA, QA and PV activities across Central & Eastern Europe.

This is an exceptional opportunity for a regulatory/quality professional who enjoys regional responsibility, cross-functional collaboration, and direct impact on compliance and patient safety across multiple countries.

What You Will Do

As the RA/QA Manager for the CEE region, you will be responsible for ensuring compliant and effective execution of Regulatory Affairs, Quality Assurance, and Pharmacovigilance activities, in close cooperation with global teams and local partners.

Regulatory Affairs

• Coordinate regulatory implementation across CEE (MAP processes, labeling updates, lifecycle variations).
• Ensure linguistic reviews and cooperation with local regulatory partners.
• Monitor regulatory changes in CEE legislation and provide strategic impact assessments.
• Lead adaptation and deployment of aRMM materials.
• Manage regional regulatory vendors and ensure timely execution of local RA tasks.

Pharmacovigilance

• Manage regional PV vendor operations, contracts, and SDEA compliance.
• Oversee PV support for Market Research and Patient Support Programs, including controlled distribution.
• Coordinate PV training and re-training for external service providers.
• Lead Medical Information oversight (Veeva entries, quarterly review meetings).

Quality Assurance

• Maintain and continuously improve the CEE Quality Management System (QMS).
• Ensure audit readiness and support inspections.
• Manage Product Quality Complaints (PQC) and CAPA documentation.
• Support quality monitoring and process improvements in alignment with global standards.
• Governance & Reporting
• Prepare RA/QA/PV governance reports for monthly and quarterly CEE+ review meetings.
• Identify improvement opportunities that enhance regulatory and quality excellence.

Who We Are Looking For

• Degree in Pharmacy, Life Sciences, Chemistry or a related field.
• At least 3 years of experience in Regulatory Affairs, Quality Assurance or Pharmacovigilance (ideally in a multi-country EU environment).
• Experience with variations, renewals, lifecycle management, audits, CAPA and vendor management.
• Strong knowledge of EU RA/PV/QA requirements and GxP frameworks.
• Excellent communication skills and ability to work cross-functionally.
• Fluent English (B2+) and fluency in at least one major CEE language.
• Clean driving licence + willingness to travel occasionally.

What’s Offered

• Key regional position with high visibility and strategic impact.
• Chance to work closely with global RA, QA and PV teams.
• Dynamic, mission-driven environment focused on innovation and patient well-being.
• Competitive compensation and benefits package.