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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.

YOUR RESPONSIBILITIES:

  • 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

YOUR REQUIREMENTS:

  • 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: applications.hr.vie@valneva.com

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

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