Requirements: English
Company: CK Group
Region: switzerland ,
Job Title: Senior Regulatory Affairs Specialist
Location: Lucern
Salary: Up to 63.00 CHF per hour
CK QLS are recruiting for a Senior Regulatory Affairs Specialist, to join a growing biopharmaceutical company, at their site based in Lucern. The position is offered on a 12 month contract, with the possibility of extension.
Senior Regulatory Affairs Specialist Role:- 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.
Further Responsibilities will Include:- Maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
- Timely preparation and maintenance of local labels and packaging materials.
- High quality translations and check of labels.
- Efficient and consistent implementation and use of internal and external regulatory databases and systems in Switzerland.
Your Background:- 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 (reading documents).
- Familiarity with Swiss and (if applicable) EU legislation procedures and guidelines governing pharmaceutical products; knowledge of the regulatory framework for vaccines is advantageous.
Apply:
Please could you send any correspondence in English. Please quote job reference in all correspondence. It is essential that applicants hold entitlement to work in Switzerland.