To help our clients with their projects, we are looking for a junior regulatory affairs specialist to joint our team of experts in Switzerland.
To support the Regulatory Affairs Submissions team in the frame of new registrations and maintenance of the registered products (prescription drugs) mainly for international countries (excluding US) and ad-hoc support for European countries.
Activities and responsibilities
Coordinate the constitution and/or tracking of registration, variation or renewal dossiers
Assure timely receipt and dispatch of administrative documents and their legalization (if applicable) necessary for registration, renewal and variation files (including but not limited to Certificate of Pharmaceutical Products, Free Sale Certificates, Letter of Authorization, GMPs, Price certificates)
Support the team in terms of uploading documentation in our EDMS system, put in place tracker for Regulatory Affairs Database update
1-2 years of experience in regulatory affairs, ideally in a global organization for international countries such as Middle East, CIS or Latin America
Experience in a multinational environment
Experience in the pharmaceutical industry and use of Electronic Document Management System, regulatory affairs database
Required Skills and Knowledge
BSc in Scientific or equivalent experience
Planning, organizing and time management skills
Ability to deal with rapid change
Fluent in English; French and/or Spanish is a plus
Mobility : Lausanne area