CSL Behring is one of the world's leading manufacturers and providers of innovative, life-saving pharmaceuticals made from human plasma as well as related treatments. The company has approximately 12,000 employees globally, of which there are about 2,300 in Germany at the largest production and research location of CSL Behring in Marburg.
People who work for CSL Behring are committed to saving the lives of patients throughout the world. This involves top performance, as we strive to be the best. Join our team in the Global Regulatory Affairs department as a
Labeling Manager – Company Core Data Sheet Owner
The Labeling Manager - Company Core Data Sheet (CCDS) Owner, Therapeutic Area (TA) Lead drives the creation and maintenance of the development CCDS (dCCDS) and the CCDS, the core product labelling reference documents during development and for market products, respectively, for the CSL Behring products of the TA Coagulation and Critical Care.
Create and maintain the dCCDS and CCDS for the CSL Behring products of the TA Coagulation and Critical Care. Accountable for the world-wide regulatory submission and approval process of new CCDS’s and CCDS updates in regional or local product labelling. Play an active role in ensuring a compliant end-to-end global labelling process.
Interact with relevant experts departments and stakeholders, like Global Clinical Safety and Pharmacovigilance, Global Clinical Development, and Commercial Development and Operations, regarding the CCDS content and content updates.
Interact with the Regional Labelling Specialists, responsible for the implementation of new CCDS’s and changes to the CCDS in the regional and local product labelling. Support Regional Labelling as needed.
Provide leadership and direction to CCDS owners. Drive their performance, define training needs, and carry out annual performance review bases on predefined objectives.
Advanced degree in a life science preferred (Master’s degree), at minimum a Bacherlor’s degree
Experience in a Global Regulatory Affairs function with extensive knowledge of regulatory product labelling and related processes
Excellent oral, written and interpersonal communication skills (in English)
Attention to detail
Organizational and project management skills
Planning, organizing and time management skills
Ability to work under pressure
Able to operate with minimal to no supervision
Ability to travel domestically and internationally
What you need to know
CSL Behring offers an adequate, performance-oriented salary with an attractive bonus system as well as an excellent company retirement plan consisting of early pension schemes and a top-notch supplementary retirement provision. Our employees also have the benefit of flexible working hours. In order to optimally coordinate career and family, we offer an option at our day-care centre for small children, as well as school vacation care for school-aged children and an option for caregiver leave.
Interested? Then we are looking forward to receiving your comprehensive Online-Application.
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