Job Detail

Stellenbeschreibung

CSL Behring is a global biotherapeutics leader driven by its promise to save lives.

In Bern more than 1500 employees develop and deliver life-saving therapies to treat people with rare and serious medical conditions worldwide.

For our Global Regulatory Affairs department in Bern, we are currently looking for a

Global Regulatory Affairs CMC Scientist (f/m), limited until 10/2020

Main Responsibilities and Accountabilities

• Responsible to work in an efficient, productive and harmonized fashion to be the CMC regulatory subject matter expert for the assigned tasks and activities. Contributes to the development of global regulatory processes in agreement with his/her supervisor.


• Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates.


• Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates.


• May be appointed as Global Regulatory Lead for established products which are no longer in clinical development.Responsible for the compilation and maintenance of facility and equipment information for regulatory submissions.


• Acts as primary GRA contact point interfacing with relevant local technical expert departments. May represent Global Regulatory Affairs in Core Project Teams for CMC projects as an expert for regulatory questions related to facility and equipment.

Qualifications & Experience

• University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous 1 to 3 years of experience in the biotech or pharmaceutical industry.


• Sound knowledge in natural sciences with a focus on biological medicinal products.


• Excellent communication, project management, planning, problem solving and presentation skills.


• Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management.


• Strong organizational and follow-up skills, as well as attention to detail.


• Ability to work with minimal supervision based on sound technical and analytical judgment.


• Flexibility to work in a global cross-cultural work environment.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring is committed to provide equal employment opportunity for all.