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30.06.2020

Global Regulatory Affairs CMC Scientist/Manager (80-100%) (m/f/d)

  • 3014CH-3014 Bern
  • Teilzeitstelle 80-100%

CSL Behring ist eines der weltweit führenden, auf die Herstellung von Plasmaprodukten spezialisiertes Unternehmen. Sein breit gefächertes Spektrum von Therapeutika umfasst Produkte zur Behandlung von Hämophilie und anderen Blutgerinnungsstörungen, Immunglobuline zur Prävention und Behandlung von Immunstörungen, Substanzen zur Verhinderung von Blutgerinnseln, Wundheilungsmittel zum Einsatz bei grösseren chirurgischen Eingriffen und Kolloide, die unter anderem zur Behandlung von Schock, Verbrennungen und Kreislaufstörungen verwendet werden. Darüber hinaus betreibt CSL Behring ein eigenes Netzwerk von Plasmaspendezentren CSL Plasma, das zu den weltweit grössten seiner Art zählt. In Produktionsanlagen neuester Technologie in Bern, Schweiz; Marburg, Deutschland; Kankakee, USA und Broadmeadows, Australien stellt CSL Behring hochwertige Medikamente nach internationalen Sicherheits- und Qualitätsstandards her. Die Produkte werden weltweit vertrieben. CSL Behring bietet eine breite Produktpalette in Indikationsgebieten wie Gerinnungsstörungen, Immundefekte, Wundheilung und Intensivmedizin. In der Schweiz versorgt CSL Behring Patienten mit 21 verschiedenen Arzneimitteln auf Plasmabasis sowie einem rekombinanten Faktor VIII-Präparat. Eine innovative Pipeline soll auch in Zukunft gewährleisten, dass Menschen, die auf unsere Produkte angewiesen sind, auf der ganzen Welt bestmöglich versorgt werden. Sicherheit und Qualität seiner Produkte stehen für das Unternehmen an erster Stelle. Deshalb sieht das CSL Behring Sicherheitssystem ein strenges Auswahlverfahren für das gespendete Plasma vor: Hochmoderne Technologien zur Prüfung und Qualifikation von Plasmaspenden, mehrstufige Reinigungsprozesse zur Virusinaktivierung und -elimininierung sowie umfassende Testungen. CSL Behring beschäftigt weltweit rund 11‘000 Mitarbeitende und betreibt Produktionsstätten, Plasmasammelzentren sowie global vernetzte Forschungs- und Entwicklungsstandorte innerhalb der CSL Gruppe. CSL Behring ist eine Tochtergesellschaft von CSL Limited, einem weltweit tätigen biopharmazeutischen Unternehmen mit Sitz in Melbourne, Australien.
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Global Regulatory Affairs CMC Scientist/Manager (80-100%) (m/f/d)

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Stellenbeschreibung

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. In Bern more than 1600 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 (80-100%) (m/f/d)

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.
  • Providing 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)
  • 1 to 3 years of experience in the pharmaceutical industry
  • Sound knowledge of the global regulatory environment would be an asset, especially with international exposure (i.e. Japan or LATAM)
  • Strong background in natural sciences with a focus on biological medicinal products, ideally plasma-derived and recombinant products
  • 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.

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

Arbeitsort:

3014CH-3014 Bern