Requirements: English
Company: K-Recruiting Life Sciences
Region: Werthenstein , Lucerne
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We unite the people who make our world healthier by placing top experts with life sciences companies worldwide. Fast and reliably, with the perfect
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:
- Masters 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
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