Regional Regulatory Scientis for Csl Behring

vor 2 Wochen

Bern, Schweiz We make it GmbH Vollzeit

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 company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

Tasks
- Support life-cycle management to ensure timely regulatory submission within ICO Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU):

- 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 up-to-date,
- prepare metrics for the dispatch of life-cycle 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 life-cycle management to ensure timely regulatory submission within ICO Region (Latin-America, Middle east, Africa, CIS, Russia, Turkey and eastern Europe (non-EU):

- 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 up-to-date,
- prepare metrics for the dispatch of life-cycle 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 1-year 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
- Detail-oriented and organizational skills
- Strong knowledge in Veeva

Work hours
- Standard 41 h/ Week

Are you interested?

We look forward to hearing from you.

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