Regulatory Labelling Manager Germany

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  • Leader in rare and serious disease
  • Management opportunity
  • EU and International responsibility
  • Negotiable salary and bonus

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.

Responsibilities:

  • 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)