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

  • 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 (Swissmedic) 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

Bachelor’s degree in a scientific or related field

Group 12

  • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry for the Swiss Market
  • Proficient with the preparation of Marketing Authorisation Applications in Switzerland
  • Experience in the preparation and submission of documentation for post-approval applications in Switzerland
  • Experience in the preparation and submission of Technical/Site Transfer Applications
  • Direct experience with Swissmedic (BfArM and PEI ideally as well)
  • In-depth knowledge of the pharmaceutical regulatory framework in Switzerland
  • Experience with driving and coordinating Scientific advice meetings
  • Proven licencing experience and knowledge of Novel medicines, Biologicals, Orphan Drugs and Paediatric consideration

Group 13
Soft skills

  • Native German speaker
  • Proficient English required, ideally good French or Italian
  • Excellent organizational skills
  • Excellent communication skills
  • Excellent IT skills/knowledge
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Personal responsibility for ensuring a high standard of work
  • Experience of promotional/non-promotional activities would be an advantage
  • Knowledge and proven experience with Access Consortium and Project Orbis would be an advantage.
  • Previous experience in a consultancy environment would be an advantage

Regulatory Affairs Specialist CH - 881