regulatory affairs manager à Villars sur Glane

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

job details

publié
lieu
villars sur glane
secteur
Life Sciences
type d'emploi
temporary
référence
11818
contact
clémentine dupuis, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

Our client is a Pharmaceutical  company and they are looking for a Regulatory Affairs Manager to join their team in Geneva, Switzerland (9 months contract, can be extended).

Your responsibilities are: 

  • Manage successful submissions for new marketing authorisations, renewals, variations and line extensions for various regions worldwide .
  • Coordinate the responses to Q&A and ensure they are handled in a timely manner and in line with the approved product strategy
  • Responsibility for the designated regulatory projects with respective deadlines and forecasted budget, from regulatory assessment to strategy implementation
  • Collaboration with the CMC, International and submission groups to ensure appropriate planning and timely execution of the regulatory activities
  • Ensure compliance of dossiers with legislation and with the general requirements in respective regions
  • Support regarding preparation and handling of Aggregate Safety Reports according to internal procedures 

Your qualification:

  • Minimum 5 years worldwide of experience in within a pharmaceutical company
  • Sense of urgency, must have the drive/motivation to take action
  • Excellent English and French (written and oral)
  • Previous experience in meeting with Health agencies
  • Scientific or Medical degree (pharmacy, chemistry or, biochemistry)
  • Strategic thinking and acting, strong analytical and entrepreneurship skills

An exiting opportunity in a growing international organization with strong focus on professional growth and continuous learning. The role offers a diversified field of activity and the inclusive culture embraces diversity of thought and empowers individuals to think as entrepreneurs.

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.