GRA CMC Scientist/Manager
CSL
Bern, Berne, Switzerland
vor 12 Tg.

Job Description

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 / Manager

Main Responsibilities and Accountabilities :

  • 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.
  • Contributes to the review of the CMC sections of the Investigator’s Brochures and product information / package leaflets.
  • Contributes to the review of CMC related information for marketing product monographs and other promotional marketing documents.
  • Responsible for regulatory support during international Health Authorities Inspections or Customers Audits.
  • Assesses and communicates inspectional findings applicable to product(s).
  • Qualifications & Experience :

  • BS / BA / Masters / PhD in Natural Science (Preferably a degree in Regulatory Affairs)
  • Experience in the pharmaceutical industry, knowledge of the global regulatory environment
  • Strong background in natural sciences with a focus on biological medicinal products, ideally plasma-derived and recombinant products
  • Excellent communication, project management, planning, problem solving and presentation 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.

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

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