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EMEA Regulatory Labelling Associate Manager Boudry Switzerland,  

Posted on : 26 January 2017

Project Description

Req #: 17000070 Location: BOUDRY, NE CH Job Category: Regulatory Affairs Work Location: Boudry, Switzerland Route de Perreux 1 Boudry 2017 Organization: Celgene R&D Sarl Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Manager Travel: Yes, 10 % of the Time DescriptionGeneral Activities: " 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   *LI-SL1QualificationsCompetencies 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. Previous experience: " 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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