Regulatory submissions to health authorities worldwide; Support submission planning including applying intelligence and develop regulatorystrategy Support preparation and maintenance of regulatory files Support submission of regulatory files, response to questions from health authorities andmaintenance of marketing authorisations globally, e.g.: MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, postapproval changes and commitments
Regulatory submissions to health authorities worldwide; Support submission planning including applying intelligence and develop regulatorystrategy Support preparation and maintenance of regulatory files Support submission of regulatory files, response to questions from health authorities andmaintenance of marketing authorisations globally, e.g.: MAA/NDA/BLA, NBO, CE, CTA/IND, Device File, Site Master File, renewals, postapproval changes and commitments