CMC / Regulatory Expert (m/w/d) - befristet

Aplitrak - Ende - 06-08-2020 zur Vakanz  

Aktuell unterstützen wir einen unserer Kunden bei der Suche nach temporärer Unterstützung im Bereich CMC / Regulatory Compliance.

Aufgaben: 

Regulatory Compliance:
  • Supports batch release by following submission and approval to ensure the product regulatory compliance
  • Ensures that the CMC dossier is in line with manufacturing and control procedures and with dossiers approved by Health Authorities
  • Contributes to site inspections and audits
  • Supports product licenses maintenance and site registration
  • Reviews and signs-off documents like SOPs or technical reports

Change Control:
  • Assesses and manages change control activities with regulatory impact for the site
  • Provides regulatory expertise to site projects
  • Manages regulatory activities linked to change controls including updating of the CMC files CMC Documentation 

Management:
  • Supports Marketing authorisations worldwide (territory extensions, renewals, site registrations and transfers, new submissions) by writing and approving
  • Optimizes the content of CMC dossiers to facilitate the management of future changes
  • Writes ready for submission CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions and supports CMC writing performed
  • Prepares with contribution of site experts answers to questions from Health Authorities
 

Voraussetzungen: 
  • Ph.D or Master in a science/health field (e.g. Mathematic, Chemistry, Pharmacy, Biology, Biotechnology Sciences etc.) or equivalent
  • Knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends is perferrable
  • 2-5 years of direct Regulatory CMC experience is preferred
  • Technical pharmaceutical CMC experience (laboratory, manufacturing, etc.) is desirable
  • Experience of manufacturing operations, Biotechnologies, Biological products is a plus
  • Capability of resolving strategic technical and regulatory issues
  • Should demonstrate initiative, independent thinking, anticipatory foresight
  • Strong communication skills
  • Business level in German and English (written & spoken)
 

Details:
Start: ASAP
Volumen: Vollzeit / 37,5 h / Woche
Ende: 30.11.2021
 
Diese Position ist aktuell im Rahmen einer Expertenüberlassung (Arbeitnehmerüberlassung) zu besetzen.
Bei Interesse freue ich mich auf Ihre Rückmeldung.
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