Global Regulatory Affairs Cmc Scientist in The

vor 7 Monaten

Bern, Schweiz CSL Behring Vollzeit

Do you want to work in a global team and support worldwide registrations for Albumins?

The Global Regulatory Affairs CMC Scientist is part of a global team of eight responsible for over 150 Albumins licenses in almost 100 countries worldwide. Albumin is manufactured at four CSL Behring sites and contributes significantly to the companies’ revenue. The role will collaborate globally with internal and external stakeholders and includes the commitment to continuous improvement and tight collaboration. The role reports to the Global Regulatory Affairs CMC Albumins Lead.

**The Role**
- Compiles relevant documentation for CMC submissions considering regional specific requirements
- Authors the CMC dossier narratives for the comprehensive CTDs
- Coordinates the compilation and updates of technical documentation with expert departments
- Represents the GRA CMC in cross-functional project teams
- Evaluates the CMC technical and scientific information for compliance with regulatory requirements, identifies deficiencies and proposes strategies to remediate risks

**Your Skills and Experience**
- Bachelor or master’s degree in natural science, medicine or paramedicine from University or Applied University (FH)
- Minimum 1 year of experience in the pharmaceutical industry, sound knowledge of the global regulatory environment
- Strong background in natural sciences with a focus on biological medicinal products
- Excellent communication, project management, planning, problem solving and presentation skills
- Ability to work with mínimal supervision, with sound technical judgment and analytical skills
- Flexibility to work in a global regulatory cross cultural work environment and can work independently as well as in a team
- Fluent in English, German is a plus

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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