Save Job Back to Search Job Description Summary Similar JobsBe part of one of the top global biopharma companies in the industryTake lead in post-marketing RA activities for the businessAbout Our ClientOne of the top global biopharma companies in the industrySpecializing in oncology, immunology, immuno-oncology, and fertilityRich development pipeline with extensive patient-centric focused products/therapiesHybrid working styleInternational working environmentJob DescriptionLead Regulatory Activities: Manage regulatory interactions with health authorities (e.g., PMDA), including clinical trial notifications and new drug applications (NDAs/sNDAs) in Japan.Documentation & Review: Prepare Japan-specific regulatory documents (e.g., Japan-CTD, Module 1) and support the health authority review process.Post-Marketing Changes: Oversee post-approval regulatory changes (PCA/MCN) in coordination with the CMC team.Labeling & Promotions: Lead Japanese package insert (J-PI) creation, artwork reviews, and promotional material evaluations.Cross-functional Collaboration: Represent regulatory affairs in internal process improvements, manage vendors, and coordinate with global and local teams.The Successful ApplicantUniversity degree in scientific or related fieldPost-marketing RA activities in the global pharmaceutical industryHigh fluency in English and JapaneseTrack record of regulatory operationsWhat's on OfferCompetitive salaries and benefitsGreat work life balanceHybrid working styleAmazing career progression in RAWork with industry leaders who are solving various unmet medical needsContactZach ItozuQuote job refJN-062024-6462818Phone number+813 6832 8683Job summaryFunctionLife SciencesSpecialisationRegulatory AffairsSpecialisationHealthcare / PharmaceuticalLocationTokyo 23 WardsJob TypePermanentConsultant nameZach ItozuConsultant phone+813 6832 8683Job ReferenceJN-062024-6462818Company TypeForeign Multinational
