Parexel este o organizație globală de cercetare clinică ce deservește companii biofarmaceutice pe parcursul dezvoltării de medicamente noi. Activitatea sa acoperă studii clinice de fază I–IV, gestionarea portofoliilor și a studiilor, strategia de reglementare, accesul la piață și planificarea ciclului de viață. Cu peste 21.000 de profesioniști, Parexel îmbină expertiza clinică, de reglementare și terapeutică cu perspectivele pacienților și designuri inovatoare ale studiilor. Compania sprijină cercetarea în domenii precum oncologia, neuroștiințele și bolile rare, punând accent pe eficientizarea dezvoltării clinice și pe orientarea acesteia către pacienți.
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.
Descriere
- 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
Cerințe
- 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