Regulatory Labelling Manager Germany
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We are looking to identify an experienced Regulatory Labelling Manager to oversee and run the EU and International Regulatory Labelling department for a leader in rare and serious disease.
- Provides leadership to the labelling team
- Responsible for coaching and development of team members
- Ensures sufficient team resources and adequate skills for the preparation and maintenance of regional and local product labelling texts
- Responsible for appropriate prioritization, strategic guidance and oversight of tasks with stakeholders (e.g. RRM/LRM, Print Services, GRA Region)
- Interacts with relevant stakeholders like the CCDS owners, the points of contacts in the Region boundaries, and local commercial organizations, as applicable.
- Ensures compliance with the regional/country specific regulatory requirements and procedures governing leaflets and labelling (i.e. general regulations, readability guideline, health authority templates, etc.).
- Ensures compliance of region/country specific labeling texts with the CCDS
- Ensures full compliance with the global labelling standards
- Ensures appropriate tracking of region/country specific deviations from the CCDS and bringing these deviations to the attention of the CCDS owner for decision making.
- Ensures that printed packaging materials are updated subsequent to labeling changes.
- Ensures translations of product labeling texts as required and in collaboration with local offices/third parties.
- Ensures the timely execution of readability user tests, as needed (EU specific).
- Represent the EU/INT RLE team in internal and external meetings and projects.
- Contributes to an efficient and compliant end-to-end global labeling process.
- Participates in projects to implement and improve labeling processes and systems.
Qualifications and Experience
- University degree or equivalent in a scientific discipline.
- Experience in a Global Regulatory Affairs function with knowledge of regulatory product labeling and related processes.
- Experience related to people management should be available.
- Competence in document management systems
- 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)