Regulatory Affairs Specialist

23.02. | Temporary | 100%

  • Responsible for providing regulatory administrative support
  • Coordination and submission of variations and renewals, update product information, marketing authorisation transfer and other product Life cycle management

Regulatory Affairs Specialist

Our client is one of the world's leading research-based bio-pharmaceutical companies.

Description

  • Implement Regulatory requirements during development and life cycle of the assigned product
  • Manage submission of the regulatory dossier and additional information with the Swissmedic and European agencies
  • Consult development and other internal departments on regulatory matters
  • Ensures that all aspects of regulatory affairs are properly planned and executed according to regulatory requirements
  • Keep up to date with the latest regulatory requirements with the focus on the regulatory strategy

Profile

  • At least 3 years of experience in Regulatory Affairs are required, ideally in an international environment
  • Responsible for the maintenance of tracking systems and databases
  • Maintenance of local files as well as minor translations, preparing submissions, renewals, PSURs and artwork management
  • Experience with the evaluation of change control requests
  • Experience with dossier submissions to Swissmedic
  • Experience in working in a cross-functional environment and stakeholder management
  • Fluent in English and German. Italian is highly desired and French is a plus


Job Offer

Are you currently looking for a position within an international operating, dynamic business environment and enjoy communication and working together with different nationalities and teams? If you fit in this profile, I look forward to receiving your application!

I am recruiting immediately available candidates:

Karin Souza -

Mobile phone: +41 78 208 39 60