Job Description
This a Full Remote job, the offer is available from: Hungary, Poland, Romania, Spain, United Kingdom, Ireland, Czechia, Italy, Croatia, Serbia, Oregon (USA)
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
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 TLP 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 the Artworks team 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
- 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
This offer from "Parexel" has been enriched by Jobgether.com and got a 86% flex score.
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