Senior Regulatory Affairs Specialist

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 (Apply online only) in all correspondence. It is essential that applicants hold entitlement to work in Switzerland