Valneva is a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need. Valneva 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 600 employees.
To ensure that regulatory activities and regulatory strategies concerning CMC (Chemistry, Manufacturing and Controls) are effectively executed to meet the business objectives and regulatory requirements, by acting as main support to the Regulatory Affairs Manager.
- To monitor and maintain all the required regulatory documents pertaining to CMC Modules 2+3, at Valneva Scotland Ltd
- To prepare, compile and interpret the information necessary for regulatory submissions associated with CMC Modules 2+3 for successful granting, maintenance of and variation to such licenses
- Ensure that quality standards are met and that the deliverables meet deadlines and fulfil regulatory and quality standards.
- Progress and track on time delivery of department owned Quality Management System actions and documentation.
- Perform and track the regulatory review of cross-functional owned documents (i.e QMS, Assay/Process Plans/Protocols and Reports).
- Provide general regulatory advice/strategy on quality related issues and determine whether change requests are compliant with the terms of all applicable license documentation within field of responsibility
- Provide strategic advice on licensing options and data requirements in order to facilitate process/product modifications and developments.
- Advise on compliance / regulatory requirements and strategy 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 and leadership in the implementation of site project activities
- Participate in Valneva teams involved with development and clinical trial of new Valneva products and ensure that these are developed in a manner consistent with future regulatory approval
- Responsible for keeping up to date with regulatory guidelines, regulations and monographs and advising key staff accordingly so that they may review and assess any implications
- As required, to support the preparation for and to participate in meetings with regulatory authorities and site GMP inspections.
- Ensure required training status is kept up to date and maintained and procedures performed are in compliance with cGMP at all times
- To align with other functions to ensure harmonisation of cross-functional and cross-site information
- To escalate any regulatory matters to the Regulatory Affairs Manager
- To deliver occasional training briefing sessions related to emerging regulatory trends and guidelines to key personnel
- Actively contribute to the development, maintenance, support and collaboration of an effective working environment within the team, across the site and between sites.
- Provide guidance to regulatory team colleagues
- Deputise for the Regulatory Affairs Manager and team colleagues as required and ensure owned tasks are assigned to deputies in their absence
- To undertake any reasonable duties as requested by the Regulatory Affairs Manager in accordance with company requirements.
- Degree level education or equivalent experience
- Working knowledge of EU and FDA regulatory requirements for the manufacturing and testing of biopharmaceutical products in a commercial environment
- Working experience in the application of regulatory guidelines/regulations to successful dossier preparation, submission and maintenance (CMC)
- Comprehensive understanding and working knowledge of the Biopharmaceutical industry
- Strong GxP understanding and experience
- Excellent scientific writing skills and oral communication skills
- Strong analytical skill and technical/scientific competence
- Attention to detail
- Organisational skills
- Negotiation skills