cmc - regulatory affairs - writing modules 2 and 2.3 à Aubonne

publié
contact
Clémentine Dupuis, Genève Professionals Health Care & Life Sciences
type d'emploi
temporary
postuler >

job details

publié
lieu
aubonne, genève
secteur
Life Sciences
type d'emploi
temporary
référence
11332
contact
clémentine dupuis, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

Urgent role

One of our Global pharmaceutical client is looking for a Regulatory CMC Dossier Expert or RA Affairs, 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
  • Module II and module 2.3 

Qualification:

  • At least 3 to 4 years of successful of scientific writing, with CMC regulatory experience
  • Sense of urgency, must have the drive/motivation to take action
  • Experience module 2 and 2.3 writing 
  • 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.