Regulatory Affairs Specialist (m/f)

Dienstort Wien Unternehmen Valneva Austria GmbH
Arbeitgeber entdecken
Beschäftigungsart Vollzeit Position ohne Personalverantwortung Gehaltsangabe 1.783,71 € /brutto Jetzt bewerben

Regulatory Affairs Specialist

Valneva Austria GmbH, a subsidiary of Valneva SE, focuses on pre-clinical and clinical vaccine development and QC testing. The company is located at the Campus Vienna Biocenter, a melting pot of biotechnology and life sciences in Vienna. The site with its state-of-the-art R&D and QC laboratories holds a GMP certificate from the Austrian Agency for Health and Food Safety (AGES) and was successfully licensed by the US Food and Drug Administration (FDA) for QC testing of Valneva´s marketed Japanese encephalitis vaccine.

We want to advertise a full-time position for a Regulatory Affairs Specialist (m/f) in our Regulatory Affairs team.


  • Coordinate and participate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, INDs) to competent authorities worldwide for approved and developmental products
  • Operate electronic submission tools (eCTD manager, validation tools) and electronic Data Management Systems (eDMS) used at Valneva Austria GmbH
  • Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
  • Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives
  • Provide regulatory feedback in project teams
  • Participate in contacting competent authorities for respective projects/products and interact with internal departments
  • General regulatory and maintenance tasks


  • University degree in science and/or regulatory affairs
  • 1 - 2 years’ experience in regulatory affairs, preferably with vaccines OR 2 - 3 years’ experience in a quality function in the pharmaceutical industry
  • Experience in Regulatory Life Cycle Management and eCTD is an advantage, although not required
  • Excellent English and German skills
  • Proficiency with standard Windows and Office programs
  • Experience with electronic document management systems and IT knowledge
  • Good social skills and ability to work in teams

We are legally required to publish the minimum monthly gross salary for this position according to the collective agreement of € 1.783,71 (full time). Please note that this is the minimum salary and our offered salaries are higher, based on qualification and experience.

If you (m/f) are interested in this challenging position in an international surrounding, please send your application (Ref.Nr. 11233-17-01) to the Human Resources Department:

Valneva Austria GmbH
Roseleen Seidl
Campus Vienna Biocenter 3
1030 Wien
Tel: +43 1 206 20 1348

ähnliche Jobs

Jobempfehlung senden
Folgenden Job empfehlen:
Regulatory Affairs Specialist (m/f)

Möchten Sie sich anmelden?

Um Ihre Merkliste dauerhaft zu speichern, melden Sie sich bitte mit Ihrem Benutzerkonto an.

Falls Sie noch kein Benutzkonto besitzen können Sie sich kostenlos registrieren

Ohne Anmeldung fortfahren Anmelden