Senior Regulatory Affairs Consultant - Labelling (home or office based)

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 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 This offer from "Parexel" has been enriched by Jobgether.com and got a 0% flex score. Apply tot his job Apply To this Job