Global Regulatory Affairs Rare Diseases Apprentice H/F
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About The Position
The position offers a 12 months apprenticeship in Global Regulatory Affairs, TA (oncology, neurology or rare disease). The apprentice will support global regulatory development and registration plans supporting commercialization, both pertaining to Europe/US/Canada/China/Japan. The role includes participation in strategic and operational tasks/discussions for early and/or late stage programs, regulatory coordination, and contribution to the drafting and implementation of the regulatory strategy for specific projects. The apprentice will ensure that the needs for their region are adequately reflected and will support the coordination of the preparation with relevant functions and the assembly of regulatory documentation to be submitted according to the validated strategy. Additionally, the apprentice will contribute to critical and constructive review of regulatory dossiers, ensure quality authoring of core-administrative parts of submission packages, and work on the content of regulatory submission dossiers in collaboration with the GRA Director. The role also involves ensuring adequate planning and timelines management, attending/driving cross-functional meetings, and supporting marketing authorization procedures.
