regulatory affairs manager - fluent in russian à Villars sur Glane

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

job details

publié
lieu
villars sur glane
secteur
Life Sciences
type d'emploi
permanent
référence
12037
contact
clémentine dupuis, genève professionals health care & life sciences
téléphone
058 201 54 40
postuler >

description du poste

One of our client based near Geneva is looking for a Regulatory Affairs Manager. The candidate needs to be fluent in Russian and have good command in French & English. 

Responsibilities: 

  • Keep up to date with the latest regulatory requirements with the focus on the regulatory strategy in Europe and APAC.
  • Act as Point of Contact between Regulatory Affairs of the partner company, local regulatory representatives of company and corporate or regional stakeholders
  • Manage the response to Health Authority questions / requests for information
  • Ensure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Regulatory Affairs such as the Therapeutic Groups, Labelling, Reg Ops and CMC
  • Responsible for ensuring successful dispatch and submission of new marketing authorizations, life cycle management (variation filings, extension applications etc.) in the assigned territory
  • Support GMP inspections of manufacturing sites by competent authorities (i.e. EAEU, Russia, Belarus, Kazakhstan and China inspections)

Profile: 

  • Degree in Life Sciences, Pharmaceutical Sciences or Medical
  • At least 5 years of experience in Regulatory Affairs in the EurAsian Economic Union and APAC markets
  • Fluent in Russian and Good command of French, English 
  • Ability to analyze the regulatory requirements and perform comprehensive gap assessments and build effective regulatory strategies

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.