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Regulatory Compliance Packaging Expert

vor 2 Monaten

Marburg an der Lahn, Hessen, Deutschland OSB AG Vollzeit

Join Our Team as a Clinical Supply Packaging Specialist

Your Role:

  • Take charge of planning and coordinating the labeling, packaging, and distribution of investigational medicinal products (IMP) for international clinical programs, including Investigator Initiated Trials (IITs).
  • Ensure adherence to regulatory standards in IMP label text translations and provide expert consultancy to study teams on packaging matters.
  • Oversee material master data, packaging strategies, and the demand for packaging components, while managing SAP-based packaging orders and coordinating test sample supplies.
  • Guarantee compliance with country-specific regulations by creating and maintaining study-specific label text and coordinating the printing of labels.
  • Support global departments in IITs by advising on packaging design, managing supply concepts, and coordinating the delivery of packaged products.
  • Supervise quality aspects such as the development of Standard Operating Procedures (SOPs), change management processes, and contribute to audits and inspections.
  • Lead discussions with global study teams and external partners to establish packaging and labeling strategies, and actively participate in relevant study team and CTS meetings.

What We Are Looking For:

  • A University Degree in Logistics, Economics, or equivalent professional experience.
  • Strong understanding of clinical supply packaging processes, including GMP, GDP, and GCP regulations.
  • Familiarity with international regulations concerning the labeling of investigational medicinal products.
  • Ability to navigate a matrix organizational structure effectively.
  • Fluency in English is essential.

Why OSB AG?

  • Permanent Employment Opportunities
  • Competitive Salary Packages
  • Flexible Remote Working Options
  • Personalized Training Programs
  • Flexible Working Hours
  • Engaging Employee Events
  • Wellness Programs