Job Description In your role as a Regulatory Affairs Manager, you will be involved in the development of ATMPs. You will support the Regulatory Affairs department in preparing and reviewing approval documents for our products in cell and gene therapy. You will compile dossiers and take care of the submission of applications to the relevant national and international authorities, with a focus on clinical trials. In this context you, will also interact with clients and support them with their applications. You identify and communicate regulatory requirements and provide regulatory advice on the development and maintenance of products to the team (e.g. R&D, Manufacturing Quality Control, Marketing & Sales). Furthermore, you review documents from a regulatory perspective. You support the team in providing regulatory assessment of changes, such as manufacturing process changes (change control). This includes the determination of the impact of the change on regulatory filings and the preparation of appropriate documents.