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

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 (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

Bachelor’s degree in a scientific or related field

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

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