Regulatory Operations Specialist (m/f/d) – freelance – on hold

  • Position zu besetzen ab 13. Dezember 2019
  • Permanent-ID OCR-FL-870
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 2x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Task:

• Technical check of documents (check against CTD requirements)
• Technical compilation and publishing of regulatory documentation (e.g. dossiers in the eCTD/Nees format)
• Preparation for dispatch and dispatch of regulatory documentation (electronic / paper), electronic submission (e.g. burning CDs, EUDRALINK, ESG, CESP, PSUR Repository)
• Tracking and maintenance of product’s lifecycle data (e.g. Regulatory Information Management System (RIMS), Submission tool, e.g., docuBridge)
• Takes full responsibility for archiving, retrieving, tracking and communicating regulatory information and data (e.g. Submissions, Authority letters, data on products lifecycles)

Skills:

• Solid experience in submission management for pharmaceutical products
• Experience in validation, publishing and transmission as well as experience in Life Cycle Management (RIMS)
• Languages: English fluent, German business fluent

 

Additional Information
Location: Hamburg (Reinbek)
Project start: 13.12.2019
Duration: ca. 3 month
Availability: 4 days / week
On-site: 50 %
Remote: 50 %

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