We make it GmbH is a company operating nationally in Switzerland which thanks to many years of successful experience has a high level of expertise in the personnel services sector.

Its recruitment activities are focussed on the core areas of industry technology office/administration engineering pharmaceuticals and IT. We make it GmbH places the highest demands on quality ethics and discretion.

For our client CSL Behring based in Bern we are looking for a Regional Regulatory Scientist (m/f/d).

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients needs by using the latest technologies we develop and deliver innovative therapies that treat coagulation disorders primary immune deficiencies hereditary angioedema respiratory disease and neurological disorders. The companys products are also used in cardiac surgery burn treatment and to prevent hemolytic disease of the newborn.

Tasks

Support lifecycle management to ensure timely regulatory submission within ICO Region (LatinAmerica Middle east Africa CIS Russia Turkey and eastern Europe (nonEU) :
collect the documentation
prepare cover letter and request translation as required
request and track the labelling update as appropriate
verify the completeness of the documentation package
dispatch the documentation
maintain our tracker uptodate
prepare metrics for the dispatch of lifecycle management activities within ICO Region.
Interact with Global Labelling or SMEs as required
Monitor local regulatory activities to ensure business objectives and timely implementation.
Support GRA Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region ).
Support lifecycle management to ensure timely regulatory submission within ICO Region (LatinAmerica Middle east Africa CIS Russia Turkey and eastern Europe (nonEU) :
collect the documentation
prepare cover letter and request translation as required
request and track the labelling update as appropriate
verify the completeness of the documentation package
dispatch the documentation
maintain our tracker uptodate
prepare metrics for the dispatch of lifecycle management activities within ICO Region.
Interact with Global Labelling or SMEs as required
Monitor local regulatory activities to ensure business objectives and timely implementation.
Support GRA Intercontinental team members to obtain and maintain registration of products within ICO Region in collaboration with the local regulatory teams within the Region ).

Requirements

A degree in Biological or Medical Science or Pharmacy or equivalent
At least 1year professional experience in Regulatory within international markets and / or labeling activities
Fluent in English and any other language as Spanish French Arabic Russian is an advantage
Good communication skills
Detailoriented and organizational skills
Strong knowledge in Veeva

Work hours

Standard 41 h/ Week

Are you interested

Then Mr Andr Amstad looks forward to receiving your complete application documents (CV references and training certificates).

We look forward to hearing from you.

Regional Regulatory Scientis for CSL Behring