Senior Regulatory Affairs Specialist 479

In the frame of a new project, we are looking for an experienced Regulatory Affairs Specialist for the following tasks, in order to contribute to the implementation of the regulatory strategy for the development and registration of oncology project :

• Regulatory referral for all requests concerning the products under his/her responsibility
• Develops in collaboration with the Regulatory Affairs Divisions concerned the regulatory strategy for the products for which he/she is responsible by evaluating the different local and global options
• Contributes to the construction of the global NCE/NBE development plan for the product for which he/she is responsible
• Participates in the preparation and/or revision of all documents required for the authorization and follow-up of clinical studies, as well as in the drafting of responses to the competent authorities and ensures the consistency of information between the various documents
• Organizes and manages the preparation of meetings with local or global competent authorities
• Participates in the organization, with all necessary internal structures, of due diligence aimed at establishing new partnerships for anti-cancer products
• Is proactive in providing advice and opinions as needed to participate in the preliminary evaluation of product candidates for licensing-in in collaboration with other departments/divisions/management
• Prepares the regulatory analysis of the product candidate for licensing-in, contributes to the development and registration strategy, and participates in the recommendation prepared for the Executive Management for the therapeutic area under his/her responsibility
• Participates in the preparation and review of the relevant parts of the licensing agreement