Regulatory Affairs CMC Manager (m/w)

  • Referenznummer: 3285
  • Branche: Pharma
  • Einsatzort: Bayern
  • Beschäftigungsform: Freiberuflich
  • Beginn des Projekts: 01.04.2018
  • Ende des Projekts: 31.08.2018
  • Dauer: 4 Monate
Ihre Aufgaben:
  • Consulting to regulatory Life Cycle Management in quality related issues
  • Development of regulatory strategies for several quality related variations
  • Review and approval of scientific documentation intended for quality related Regulatory Affairs activities
  • Compilation of quality related documents for: Renewals and Variations
  • Coordination and preparation of response documents to regulatory authorities
  • Follow-up of regulatory and legal deadlines and coordination of the implementation.
Ihre Qualifikationen:
  • Masters degree in Natural Science preferably in Pharmaceutics
  • Experience in writing the CMC part of the dossier
  • Ability to coordinate and manage the completion of multiple projects simultaneously
  • Proficiency in document management systems