Company: Key People Limited
Closing Date: 08 Dec 16
Salary (£): 80,000 - 100,000
A Blue Chip Pharma based in Base, Switzerland, is currently seeking a Regulatory Labelling Manager to join their team on an initial 12 month contract basis. Within this role you will be responsible for supporting the development of and managing the maintenance of the company's Core Data Sheets (CDS) and associated product information documents.
A Blue Chip Pharma based in Base, Switzerland, is currently seeking a Regulatory Labelling Manager to join their team on an initial 12 month contract basis. Within this role you will be responsible for supporting the development of and managing the maintenance of the company’s Core Data Sheets (CDS) and associated product information documents.
• Provides strategic labelling support to teams and generate labelling scenarios for products throughout their development and maintenance lifecycle
• Take the lead and responsibility for complex CDS maintenance and development activities including the planning, creation of timelines and project management for CDS activities.
• Provide support for other CDS-related activities and initiatives as required.
• Support the implementation of CDS changes into the Local Product Labels (LPLs) and have involvement in tracking local label compliance and local label deviations.
• Support the review process for Product Label changes received from outside of the company (e.g from Health Authorities).
• Provide competitive labelling comparisons as required for CDS preparation.
• Support the Labelling Management team in the training of Program and Product teams on CDS policies and procedures.
• Maintain an overview of relevant global regulatory labelling requirements
• A B.Sc. in a life-science subject or in a closely related discipline and solid experience/expertise in regulatory affairs (preferably labelling).
• Experience of developing or maintaining core data sheets for medicinal products.
• An excellent team worker with well-developed interpersonal skills.
• An accomplished communicator with good written and verbal communication skills.
• Able to successfully plan and organise your own workload.
• Committed to producing high quality outputs and demonstrate excellent attention to detail.
• Able to use Microsoft Office.
For further details about this role, please call Tim Barratt on +44(0)1727 817 626 or email email@example.com
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|Fax:||Fax: 44 (0) 1727 844838|
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