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EMEA Regulatory Labelling Associate Manager

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


General 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




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.

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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