Lead implementations end-to-end. Run kickoff calls with customer regulatoryteams, understand their specific dossier types, document templates, and submissionworkflows, and configure Zenopsys to fit how they actually work.● Translate regulatory needs into product configuration. Map customer sourcedocuments, authoring conventions, and review rules into our platform. Validate thatoutputs (drafted sections, citations, compliance checks) meet the
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
23 april 2026
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