• Assist with the preparation, maintenance, and finalisation of labelling texts per product for internal review before submission to regulatory authorities;
• Coordinate the provision of labelling Annexes to Regulatory Affairs during product development to ensure ongoing alignment with clinical, regulatory and commercial strategies;
• Ensure compliance with current EU regulations, guidances and templates. Have confident ability to discuss these guidances in project meetings;
• Act as the Subject Matter Expert for EU Regulatory Labelling guidance and answer any technical or procedural queries relating to them;
• Manage the process for providing translations of Product Information (PI) in multiple languages (centralised procedure) within strict European Medicine Agency (EMA) procedural timelines;
• Coordinates translation, review, submission to Member States (MS), discussion of MS’s proposed changes and final submission of language PIs to EMA;
• Performs quality control of language PIs ensuring: compliance with EN PI and language-specific Quality Review of Documents (QRD) templates/guidelines and terminology consistency within language PI/across other Celgene approved PIs;
• Versions, archives and distributes final PI for internal use.
Responsibilities will include, but are not limited to, the following:
• Responsible for review and compilation of change control workflows for updates to labelling text and artwork for multiple products marketed in EMEA;
• Manage electronic archiving of draft mock-ups and label texts, and packaging artwork, including version control and archiving;
• Liaise with Readability Testing company to monitor progress of new and ongoing tests;
• Manage the development and maintenance of the core abbreviated product information documents;
• Liaise with Product Lifecycle Management teams to progress labelling content into printed packaging materials.
• Deputise for Associate Director, Regulatory Labelling in his/her absence
Competencies and Behaviours:
• Monitor compliance with labelling SOPs and working practices;
• Detailed understanding of global drug development;
• Detailed understanding of SmPC development, regulatory submissions, and approval processes, including labelling requirements throughout the product lifecycle;
• Timely and effective collaboration and alignment with department stakeholders
• Escalate issues and concerns to team leader;
• Expected to proactively ask questions to clarify understanding;
• Build knowledge by supporting the team in analysing and processing labelling components;
• Being driven by a constant eye for quality and attention to detail
• Prepared to answer questions during authority inspections and during internal audits on processes
• Confident with data input for document management systems.
• Ability to prioritise workload and handle multiple projects.
• Excellent writing, editing and proofreading skills with attention to detail.
• Demonstrated ability to interact effectively with cross-functional teams and regulatory agencies.
• Scientific background desirable.
• Experience in quality control of documents in different languages and format.
• Experience of working on large and demanding translation projects managed in team and autonomously.
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