Regulatory Affairs Specialist (m/f/d)

Regulatory Affairs Specialist (M/F/D)

Tasks:

• Ensure timely preparation and submission of new local Marketing Authorization applications for assigned products as well as appropriate follow-up with the local authorities

• Track process and manage answers to objections from the regulatory authorities on products registration and major new indications, involving negotiations to achieve best conditions

• Participate in subsidiary product and launch teams to provide regulatory input and strategy advice

• Ensure maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations

• Ensure timely preparation and maintenance of local labels and packaging materials

• Ensure high quality translations and check of labels

• Ensure efficient and consistent implementation and use of internal and external regulatory databases and systems in Switzerland

Qualification:

• Master’s degree in Pharmacy or another relevant life science discipline

• At least 2 years of experience in a registration department, regulatory agency or another related environment in Switzerland

• Fluency in German and English is required, good level of French and/or Italian

• Familiarity with Swiss and (if applicable) EU legislation procedures and guidelines governing pharmaceutical products; knowledge of the regulatory framework for vaccines is advantageous

• Ability to communicate well verbally and in writing is essential

• Strong attention to detail; proven ability to successfully handle conflicting time pressures and a large volume of work

• Pronounced client focus and business orientation

• Strong organizational and business planning skills

• Proficient use of MS Office suite and relevant database application

Requirements: 

Start: 16.06.2025

Duration: 12 months

Capacity: 5 days per week

Location: Werthenstein, Switzerland