Role DescriptionThe Regulatory Management Center (RMC) is a new regional organization to handle the activities of local operating companies in EMEA, Asia Pacific and Latin America. At the RMC they handle tactical processes, regarding CMC Variations and Labeling Changes in the region.
The responsibility of RMC Submission Management is to lead wide range submission processes for multiple countries, preparing country-specific submission ready dossiers,manage Agency questions when required and ensure post-approval activities to take place for those submissions.
ResponsibilitiesYou will work on routine regulatory affairs maintenance activities (variations) for MRP and NP products, servicing mainly the North European countries (Baltics, Nordics, Benelux, UK, Ireland, Germany). You will be working independently in a virtual team where your colleagues will be in different locations. You will not be working strategically, but mainly be focussed on submission and implementation.
Requirements• A minimum of a University degree or equivalent by experience; • At least 3 years of regulatory experience; • In depth knowledge of local and regional regulations/legislation; • Experience with RA tracking systems (e.g. TrackWise / SPS / MPD) is an asset.
Other informationThe position is located in the LOC of the respective region (EMEA, Asia Pacific, or Latin America). No relocation is required.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.