求人を保存 検索に戻る 職務内容 求人情報 類似した求人Be part of one of the top global biopharma companies in the industryTake lead in post-marketing RA activities for the business企業情報One 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 environment職務内容Lead 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.理想の人材University degree in scientific or related fieldPost-marketing RA activities in the global pharmaceutical industryHigh fluency in English and JapaneseTrack record of regulatory operations条件・待遇Competitive salaries and benefitsGreat work life balanceHybrid working styleAmazing career progression in RAWork with industry leaders who are solving various unmet medical needsコンタクトZach Itozu求人番号JN-062024-6462818電話+813 6832 8683求人情報分野ライフサイエンス職種薬事・学術業界ヘルスケア・製薬勤務地東京23区雇用形態正社員担当コンサルタントZach Itozu担当コンサルタントの電話番号+813 6832 8683求人番号JN-062024-6462818企業タイプ外資系企業
