更新日 2024-04-02
掲載開始日 2024-04-02

CMC RA Manager at Global Renown Biopharma

人材紹介
マネージャーレベル

この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - その他メディカル/医薬/バイオ/素材/食品 - 薬事申請/特許技術関連メディカル/医薬/バイオ/素材/食品 - 基礎研究/応用研究/分析
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	Be part of a global renown biopharma with rich development pipeline. Take lead in CMC RA activities to obtain regulatory approval. Description * Take lead in CMC RA activities for the business to obtain regulatory approval of new/existing products * Prepare CTD documents (such as module 3) and other application form for submission * Communicate with health authorities such as the PMDA for consultations and inquiries * Collaborate with global stakeholders to align company strategies * Ensure effective regulatory compliance requirements and guidelines to ensure effective development * Identify any issues from a scientific or technical related areas to avoid any risks Profile * University degree in scientific or related area * High fluency in English and Japanese (non-native level speakers will not be selected) * Extensive CMC RA experience in the pharmaceutical industry * Strong understanding of CMC activities, regulations, and guidelines * Background in drug development process Job Offer * Competitive salaries and benefits * Great work life balance * International environment * Hybrid working style * Amazing career development in CMC RA * Work with industry leaders who are solving unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について（社風など）	* One of the top global biopharma companies in the industry * Rich development pipeline specializing in Oncology, Immunology, Immuno-Oncology, Fertility for unmet medical needs * New product launch almost every other year * Extensive communication with global HQ * Hybrid working style
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	ネイティヴレベル
年収	日本・円 1000万円〜 1300万円