Regulatory CMC - Dossier Expert - Contract in Geneva

veröffentlicht
Kontakt
Clémentine Dupuis, Genf Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Geneva, Genf
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
10766
Kontakt
Clémentine Dupuis, Genf Professionals Health Care & Life Sciences
Telefon
058 201 54 40
jetzt bewerben

Stellenbeschreibung

Urgent role

One of our Global pharmaceutical client is looking for a Regulatory CMC Dossier Expert and Technical Writer.

Your responsibilities are:

  • Lead and drive CMC regulatory activities (writing, approval,..)
  • Lead the dossier content and interaction with CMC technical functions for concerned molecules of specific focus area 
  • Provide support during Health Authority interactions on CMC registration
  • Responsible for translation and interpretation of the country regulatory requirements into CMC/Technical requirements 
  • Secure CMC Regulatory Compliance for the products
  • Responsible for the creation of the quality reference files for products under own responsibility

Qualification:

  • At least 3 to 4 years of successful of scientifc writing, with CMC regulatory experience
  • Sense of urgency, must have the drive/motivation to take action 
  • Excellent English (written and oral)

If your profile corresponds closely, please do not hesitate to send us your CV, latest certificates and the date of your availability. Only online applications will be considered. We look forward to your application.

A valid Swiss work permit OR Swiss or EU-25/EFTA citizenship is required.