[Hiring] Senior Regulatory Affairs Consultant @Parexel

Role Description

We are seeking an experienced Regulatory Affairs Professional to provide strategic leadership and execution support across the full lifecycle of medicinal product development and registration within Europe. This role is ideally suited to a regulatory professional who combines deep EU regulatory expertise with strategic thinking, strong client-facing skills, and the ability to lead complex regulatory programmes from development through post-approval lifecycle management.

In this role, you will:

• Lead and manage Marketing Authorisation Applications (MAAs), providing strategic regulatory input on both the overall application pathway and the full dossier package.
• Play a key role in the development and execution of regulatory strategies.
• Conduct critical document reviews and provide competitive regulatory intelligence to support informed decision-making and successful regulatory outcomes.
• Actively contribute to regional and global regulatory activities.
• Lead the preparation of core regulatory documents such as briefing books, paediatric development plans, scientific advice packages, and other key regulatory deliverables.
• Support investigational, new, and marketed product submissions while serving as a key interface with health authorities and cross-functional stakeholders.

The role can be home or office based in Poland, Croatia, Hungary, Romania or Serbia.

Qualifications

• University degree in a Life Science discipline.
• Significant Regulatory Affairs experience supporting EU product development and lifecycle management.
• Proven experience leading or supporting EMA interactions and regulatory procedures.
• Strong understanding of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements.
• Experience preparing and reviewing regulatory documentation, including Module 1 content and health authority briefing materials.
• Demonstrated expertise in regulatory strategy development, dossier review, and health authority engagement.
• Excellent project leadership, stakeholder management, and communication skills.
• Ability to manage multiple regulatory priorities while delivering high-quality outcomes in a fast-paced environment.
• Fluent in English, written and spoken.