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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.
Job Responsibility:
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
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
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
Requirements:
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