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.