Global Regulatory Affairs CMC Manager

Gefunden in: beBee S CH - vor 4 Wochen

Bern, Schweiz CSL Behring Vollzeit

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

Global Regulatory Affairs CMC Manager (100%) in the Albumins Team

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

The Global Regulatory Affairs CMC Scientist/Manager 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

  • Develops and executes global regulatory strategies in close collaboration with the site Quality and Manufacturing Departments and with regional regulatory experts to license product changes.
  • Develops and executes global regulatory strategies to obtain new marketing authorizations worldwide of established product in agreement with the commercial organization.
  • Represents the Global Regulatory Affairs function in cross-functional project teams.
  • Responsible for the maintenance of the content of regulatory submissions of the licensed products from the site of manufacture, meeting appropriate standards and content requirements.
  • Responsible for the compilation of relevant high-quality documentation for CMC submissions according to agreed schedules while taking into account regional specific requirements.
  • Authors the CMC dossier narratives for the comprehensive CTDs.
  • Coordinates the compilation and updates of technical documentation with expert departments.
  • Compiles CMC documentation in preparation of Scientific Advice Meetings, contributes to and participates at Scientific Advice Meetings.
  • Evaluates the CMC technical and scientific information for compliance with regulatory requirements, identifies deficiencies and proposes strategies to remediate risks.
  • Compiles the CMC part of Base Dossiers for new marketing authorization applications in relevant countries.

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 minimal 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.

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.

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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