Regulatory Affairs Specialist CH - 881

We are currently seeking a highly motivated and experienced Regulatory Affairs Specialist to join our local RA teams in Switzerland.

About us

Group 10
Responsibilities

  • Ability to input with Consultancy level expertise for Switzerland on a multitude of topics
  • Prepare and submit regulatory documentation to health authorities, both for pre-MAA (initial registration) and post-MAA (LifeCycle Management) activities
  • Be the responsible person for interactions with health authorities on behalf of PLG’s customers
  • Ensure compliance with local regulations
  • Review and interpret regulatory guidelines and provide guidance to internal teams
  • Collaborate with cross-functional teams to ensure regulatory requirements are met
  • Participate in regulatory agency meetings and audits
  • Maintain up-to-date knowledge of regulatory changes and industry trends

Group 11
Education

Bachelor’s degree in a scientific or related field

Group 12
Experience

  • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry for EU market.

Group 13
Soft skills

 

  • Proficient English required, ideally good French
  • Excellent organizational skill

Regulatory Affairs Specialist