EMEA Regulatory Labelling Associate Manager - Switzerland
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- 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