Senior Regulatory Affairs Consultant - Labelling (home or office based)
Primary Location: United Kingdom, Remote Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Ireland, Dublin; Ireland, Remote; Italy, Milan; Italy, Remote; Poland, Remote; Poland, Warsaw; Romania, Bucharest; Romania, Remote; Serbia, Belgrade; Serbia, Remote; Spain, Madrid; Spain, Remote Job ID R0000035717 Category Consulting Date Posted 09/24/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
About the Role
We are seeking an experienced Regulatory Affairs professional to join our team as a European Labelling & Promotional Regulatory Specialist. This key position provides expert guidance across a Therapeutic business unit, delivering both strategic and operational regulatory input to cross-functional teams.
The role can be home or office based in various European locations.
Key Responsibilities
EU Product Information Management:
Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labelling requirements
Serve as the key point of contact for EU Product Information for both internal and external stakeholders
Lead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPs
Deliver competitive labelling searches and contribute to TCLP for early development assets
Operational Excellence:
Ensure timely tracking and management of all EU Product Information in appropriate systems
Lead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reports
Coordinate Linguistic Review processes with LR Coordinator according to SOPs
Communicate proactively with SPA for artwork and mock-up changes, participating in Change Control Processes
Leadership & Collaboration:
Lead the Local Labelling Committee for creation, review and approval of EU Product Information
Serve on the EU Clearance Committee as primary regulatory reviewer for promotional materials
Build strong relationships with EU and Global Regulatory teams, local business partners, SPA, and PLG teams
Monitor changes in EMA labelling requirements and keep the organization informed of technology requirements
Qualifications & Skills required for the role:
University degree in a life science discipline
Strong knowledge of EU regulatory requirements for product labelling and promotional materials
Experience with electronic content management systems and regulatory SOPs
Excellent project management and organizational abilities
Outstanding written and verbal communication skills
Proven ability to work effectively in cross-functional teams
Fluent in English, written and spoken
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