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EMEA Regulatory Labelling Associate Manager - Switzerland  

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Posted on : 26 January 2017

Project Description

  • 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 Behaviors:
  •  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. 

Travel: Yes, 10 % of the Time