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: firstname.lastname@example.org
Valneva Austria GmbH
Campus Vienna Biocenter 3
Tel: +43 1 206 20 1348