Duration: 6 month contract, possibility for Remote work.
Global Product Strategy – Regulatory – Labelling EU
- 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.
- Implementation of new and updated Company Core Data Sheet's (CCDS's) of the 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
- Ensure compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labeling
- Arrange translations of product labeling texts as required and in collaboration with local offices/third parties.
- Maintain labeling databases and systems (PAS, GRDC), as needed.
- 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
- Understanding of GMP compliance, quality control procedures and documentation practices
- Excellent oral, written and interpersonal communication skills in English