Parexel is a global clinical research organization serving biopharmaceutical companies throughout the development of new medicines. Its work spans Phase I–IV clinical trials, portfolio and trial management, regulatory strategy, market access, and lifecycle planning. With more than 21,000 professionals, Parexel combines clinical, regulatory, and therapeutic expertise with patient insights and innovative trial designs. The company supports research across areas including oncology, neuroscience, and rare diseases, with a focus on making clinical development more efficient and patient-centered.
Senior Regulatory Affairs Consultant, EU Regulatory Strategy (MAA)
Support EU medicine approvals, EMA engagement, and product lifecycle strategies as a Senior Regulatory Affairs Consultant at Parexel. Lead marketing authorisation applications, regulatory dossiers, and health-authority submissions across five European countries.
Description
- Lead Marketing Authorisation Applications (MAAs), advising on regulatory pathways and dossier strategy
- Create and implement regulatory strategies aligned with development timelines and commercial goals
- Review critical documents and deliver competitive regulatory intelligence for decision-making
- Prepare briefing books, paediatric development plans, and scientific advice materials
- Own Module 1 documentation and coordinate submission preparation
- Provide timely, high-quality responses to health-authority questions and requests
- Deliver regulatory activities on schedule across assigned products and programmes
- Lead EMA pre-submission work, scientific advice procedures, and post-approval maintenance
- Coordinate with health authorities and Clinical, Medical, Safety, Quality, CMC, and Commercial stakeholders
- Advise senior stakeholders and resolve complex regulatory issues in a consulting environment
Requirements
- A university degree in a life science discipline
- Substantial Regulatory Affairs experience supporting EU product development and lifecycle management
- Demonstrated experience leading or supporting EMA interactions and regulatory procedures
- Strong knowledge of Marketing Authorisation Applications (MAAs) and CTD/eCTD dossier requirements
- Experience preparing and reviewing regulatory documents, including Module 1 content and health-authority briefing materials
- Proven capability in regulatory strategy, dossier review, and health-authority engagement
- Strong project leadership, stakeholder management, and communication skills
- Ability to manage competing regulatory priorities while maintaining high-quality delivery in a fast-paced setting
- Fluent written and spoken English