Valneva is a speciality vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 700 employees.

An opportunity has arisen within the Regulatory Affairs team for the position of Regulatory Affairs Specialist.

The main purpose of this role will be to support the Regulatory Affairs team with the preparation, compilation and interpretation of information necessary for regulatory submissions associated with CMC (Chemistry, Manufacturing and Controls) Modules for successful granting, maintenance of and variation to such licenses to meet business objectives and regulatory requirements.

Additional responsibilities associated with the role include:

  • Progress and track on time delivery of department owned Quality Management System actions and documentation.
  • Perform the regulatory review of cross-functional owned documents (i.e QMS, Assay/Process Plans/Protocols and Reports).
  • Provide general regulatory advice on quality related issues and determine whether change requests are compliant with the terms of all applicable license documentation within field of responsibility
  • Advise on compliance / regulatory requirements for process and assay development and technology transfer activities to ensure that regulatory requirements are incorporated into the planning of development work (i.e. validated, set-up and compliant with regulatory guidelines)
  • Provide regulatory support in the implementation of site project activities
  • As required, to support with the preparation for meetings with regulatory authorities and site GMP inspections and to participate in site GMP inspection

Experience

Degree level educated (or equivalent experience), the successful candidate should ideally have knowledge/experience of the manufacture of a biological product in a commercial environment, with an understanding of GMP processes.  Regulatory experience in CMC submissions (dossier preparation and maintenance) is desirable but not essential.  Candidates, who have relevant experience in the biopharmaceutical industry and want to develop their current skillset, will be considered.

Required Skills

To be successful in the role you should have good scientific writing, IT and oral communication skills with a strong attention to detail and be a self-motivated and conscientious team player with good organisational skills.  The ability to multi-task and work under pressure with changing priorities is essential.

This is a unique and exciting opportunity for someone looking to develop their career in the field of Regulatory Affairs.

100%, as soon as possible, limited for 3 years

Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical needValneva has leveraged its expertise and capabilities both to successfully commercialize two vaccines and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, the chikungunya virus and COVID-19.

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 QUALIFICATIONS

  • University degree in science and/or regulatory affairs
  • 4 – 5 years’ experience in Pharmaceutical industry preferably with vaccines
  • 1-2 years experience in Regulatory affairs
  • 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

OUR OFFER

  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 45.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.