This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Affairs Consultant - REMOTE. This role is crucial for ensuring compliance with EU product information and labeling requirements, contributing to the health sector by facilitating accurate therapeutic communications. The ideal candidate will provide strategic regulatory insight and operational excellence while collaborating with cross-functional teams. Your expertise will directly impact the quality and effectiveness of product information management across various therapeutic areas. Join us in making a difference in patients' lives through outstanding regulatory practices.
Accountabilities
Create, update and maintain EU Product Information in line with CCDS, Agency RTQ, and current labeling requirementsServe as the key point of contact for EU Product Information for both internal and external stakeholdersLead reviews, round tables, and approvals for EU Product Information in appropriate systems according to SOPsDeliver competitive labeling searches and contribute to TLP for early development assetsEnsure timely tracking and management of all EU Product Information in appropriate systemsLead Readability Testing processes including vendor selection, agreement management, questionnaire review, and submission of final reportsCoordinate Linguistic Review processes with LR Coordinator according to SOPsCommunicate proactively with the Artworks team for artwork and mock-up changes, participating in Change Control ProcessesLead the Local Labelling Committee for creation, review and approval of EU Product InformationServe on the EU Clearance Committee as primary regulatory reviewer for promotional materialsBuild strong relationships with EU and Global Regulatory teams, local business partnersMonitor changes in EMA labeling requirements and keep the organization informed of technology requirements
Requirements
University degree in a life science disciplineStrong knowledge of EU regulatory requirements for product labelling and promotional materialsExperience with electronic content management systems and regulatory SOPsExcellent project management and organizational abilitiesOutstanding written and verbal communication skillsProven ability to work effectively in cross-functional teamsFluent in English, written and spoken
Benefits
Flexible working arrangements.Opportunity to contribute to meaningful projects in the health sector.Engagement with a dedicated team of professionals.Continuous learning and professional development opportunities.Competitively remunerated position.
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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