Experteer OverviewIn this role you will author, review, and manage regulatory documents that translate clinical, nonclinical, and CMC data into compliant submissions for global authorities. You will serve on cross‐functional teams to ensure scientific rigor and regulatory alignment across the product lifecycle. You'll oversee document development for marketing applications and lifecycle updates, while guiding external writers and internal experts. This is a chance to shape regulatory strategy for rare diseases within a mission‐driven, globally integrated environment.Retribuzione / BenefitsDraft, review, and finalize regulatory and clinical documents (CTD Modules 1-2 and related addenda)Coordinate post‐approval variations and lifecycle documentationPrepare regulatory response documents (RFI, questions, objections) and designation/expedition requestsDevelop and maintain clinical study protocols and reports, investigator brochuresEnsure eCTD compliance and alignment with ICH/FDA/EMA guidelinesLead and coordinate external writers and internal SMEs; mentor junior writersSupport dossier assembly, timelines, and cross‐functional inputs; contribute to resource planning and budgetingTrain contributors on regulatory writing standards, styles, and traceabilityResponsabilitàLife science university degree; PhD or PharmD preferredExperience authoring/regulatory writing across drug development lifecycleKnowledge of FDA/EMA requirements and ICH guidelines (E3, E6, E9, M4)Ability to interpret clinical/statistical data for regulatory submissionsFluent English, strong written and verbal communicationExperience with cross-functional team leadership and project managementProficient in MS Office and Adobe Acrobat; familiarity with eCTD publishingRequisiti fondamentalipensionprivate medical insurancewellbeing programmeflexible benefits programmerelocation supportannual bonus
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