Description
Global Product Strategy – Regulatory – Labelling EUWorkload: 100%
Location: working remotely is possible but onboarding to project on site in Marburg and regular visits on site in Marburg (alternatively Bern) are mandatory.
Purpose:
• Generation and maintenance of regional and/or national product labeling texts and mock-ups compliant with current product CCDSs and in accordance with regional or local Health Authority requirements for the assigned Region.
• Timely provision of all required labeling documents needed by the Region for submissions to HAs where product label is affected.
• Subject Matter Expert, responsible for continuously collecting, understanding and communicating HA requirements and opportunities related to product labeling for new drug applications as well as licensed products for the assigned Region.
Requirements:
• University degree or equivalent in a scientific discipline
• Experience in a Global Regulatory Affairs function with knowledge of regulatory product labeling and related processes.
• Competence in documentation practices
• Planning, organizing and time management skills
• Attention to detail
• Ability to work well under pressure
• Understanding of GMP compliance, quality control procedures and documentation practices
• Excellent oral, written and interpersonal communication skills in English and German
Tasks:
• implementation of new and updated Company Core Data Sheet's (CCDS's) of CSL Behring products in the regional/local labeling of the assigned Region within the set timeframe.
• interaction with relevant stakeholders like the CCDS owners, the points of contacts in the Region boundaries, and local commercial organizations, as applicable.
• Ensure compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labeling (i.e. general regulations, readability guideline, health authority templates, etc.).
• Ensure compliance of region/country specific labeling texts with the CCDS.
• Track region/country specific deviations from the CCDS and brings these deviations to the attention of the CCDS owner for decision making.
• Ensure that printed packaging materials are updated subsequent to labeling changes.
• Arrange translations of product labeling texts as required and in collaboration with local offices/third parties.
• Plan and manage readability user tests, as needed (EU specific)
• Maintain labeling databases and systems (PAS, GRDC), as needed.
• Contribute to an efficient and compliant end-to-end global labeling process.
• Participate in projects to implement and improve labeling processes and systems.
Special upcoming topics:
• Brexit
• WFI – integration of DCP license (we have an own license for WFI in EU) into product licenses
• PMF
• Berinert RUP