The Director of Regulatory Affairs- EEMEA, based in the EMEA HQ of Moderna in Basel, Switzerland will have the opportunity to lead the regulatory strategy for the assigned region and provide regulatory support to the Sr. Dir. of Regulatory Affairs, EMEA and the General Managers/Commercial Partners of Moderna’s Affiliates, if relevant.
This is a newly created role intended for a forward looking, creative and agile regulatory Director able to anticipate and address the challenges involved in supporting the interactions with the Local Competent Authorities in the respective countries, for messenger RNA therapeutics as unprecedented new drug modality. The Director will provide regulatory support across the Therapeutic Areas including Infectious Diseases. Their support includes but is not limited to managing the regulatory interactions and marketing authorization applications in Eastern Europe, Middle East and Africa. This person will work closely with the business in the region to provide the regulatory guidance to support the overall business plans including Health Technology Assessment support. This role may also be involved with other International regulatory interactions and submissions (orphan drug designations, pediatric plans, PRIME, DSURs, MAA, etc.).