The Director of Regulatory Affairs-International based in either Spain, or the Netherlands will have the opportunity to lead the regulatory strategy within the local affiliate (Spain or Netherlands), as well as an assigned International Regulatory Strategy Project (e.g. WHO pre-qualification process, or responsibility for overseas internal markets/regions..
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 regulatory authorities for the assigned region/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 for Europe, Asia, Africa. This person will work closely with the business in the country affiliate (Spain or Netherlands) to provide the regulatory guidance to support the overall business plans. This role will also be involved with other International regulatory interactions and submissions (such as WHO pre-qualification procedure, responsibility for Regulatory interactions in Asia/Africa etc. with the help of local partner companies; orphan drug designations, pediatric plans, PRIME, DSURs, MAA, etc.)