Senior Regulatory Affairs Specialist (m/f/d)
Responsibilities
- 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
Profile
- Master’s degree in Pharmacy or another relevant life science discipline
- Solid experience in a registration department, regulatory agency or another related environment in SwitzerlandFluency 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
Benefits
- Renowned pharmaceutical company
- Attractive salary package
- Further training oppurtunities
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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