senior manager cmc compliance à Aubonne

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

job details

publié
lieu
aubonne, genève
secteur
Life Sciences
type d'emploi
permanent
référence
11684
contact
clémentine dupuis, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

Great opportunity! 

For one of our partner, we are looking for a Senior Manager CMC Compliance to be located near Lausanne.

Your responsibilities:

  • Development 2.3 & 3 phases, product development 
  • Lead and drive CMC regulatory activities: lead the dossier content and interaction with CMC technical functions for concerned molecules of specific focus area (marketed products). 
  • Provide support during Health Authority interactions on CMC reg. topics. 
  • Activities include e.g. the CMC regulatory/dossier strategy, strategic planning in collaboration with Global Regulator Affairs, authoring, review and approval of all regulatory relevant quality documents
  • Secure CMC Regulatory Compliance for the products
  • Responsible for the creation of the quality reference files for products under own responsibility
  • Responsible for performance/preparation of regulatory compliance audits/inspections at the sites including CMOs. 
  • Provide profound expertise in pharmaceutical legislation and application of current regulatory requirements for the pharmaceutical areas.
  • Lead the dossier content and interaction with CMC technical functions for concerned molecules of specific focus area (NBEs and marketed products)
  • Strategic planning in collaboration with Global Regulator Affairs, authoring, review and approval of all regulatory relevant quality documents
  • Be accountable and responsible for translation and interpretation of the country regulatory requirements into CMC
  • Secure CMC Regulatory Compliance for the products. Responsible for the creation of the quality reference files for products under own responsibility. 

Knowledge: 

  • Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
  • Minimum of 5 to 8 years of pharmaceutical industry experience
  • Strong focus on biological entities from early development through life cycle managment and at least 3 years of global CMC regulatory experience
  • Broad knowledge of regulatory requirements for CMC (EU, US)
  • English fluent

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.