Our client, a pharmaceutical company, is looking for a Senior Regulatory Affairs Specialist to join the local offices in Lucerne, serving the Swiss healthcare market.
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Reporting to the Regulatory Affairs Director, you will be responsible for new marketing authorizations, variations, renewal applications and maintenance of assigned, authorized products of the franchise. You will develop local action plans for new products and maintain strong positive business relationships with the pharmaceutical organization, the local agency and further key players in the regulatory environment. Furthermore, you will participate in subsidiary product and launch teams to provide regulatory input and strategy advice.
General Information:
- Start date: ASAP (ideally 16.06.2025)
- Contract duration: 1 year
- Extension: to be discussed
- Workload: 100%
- Workplace: Lucerne
- Home office: hybrid role
Tasks & 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
Your profile:
We’re addressing candidates with a track record in drug regulatory affairs in Switzerland and a good understanding of relevant Swiss and/or EU legislation procedures and guidelines, ideally with previous experience in supporting a product launch. Related knowledge in vaccines or oncology products is beneficial but no prerequisite.
Qualifications:
- 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
- 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
