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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Senior Regulatory Affairs Consultant - Labelling (home or office based)
Job ID R0000035717 , United KingdomAbout 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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