CMC RA Associate Director at Top Global Pharma | 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.の求人詳細

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更新日 2024-10-01
掲載開始日 2024-10-01

CMC RA Associate Director at Top Global Pharma

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
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	Take lead in CMC RA activities to obtain product approval. Collaborate with local/global CMC RA teams to align overall business strategies Description * Take lead in CMC RA activities to obtain product approval * Plan and manage CMC programs and projects to effectively collaborate with cross functioning teams in timely matter * Prepare, develop, and submit CMC dossiers, renewals, and other essential documents for regulatory submissions * Execute regulatory CMC strategies to align with overall business objectives * Communicate, negotiate, and collaborate with local health authorities (PMDA, MHLW, etc.) as the CMC representative * Partner with other departments such as manufacturing, quality, technical services, etc. to provide key guidance from a CMC standpoint * Develop CTD documents to ensure local compliance and regulations Profile * University degree in scientific or related environment * Extensive CMC RA experience in the pharmaceutical industry (biological area preferred) * High fluency in English and Japanese (non-native level speakers will not be selected) * Strong understanding of local regulations and CTD requirements * Ability to communicate with global stakeholders and local regulatory authorities (PMDA/MHLW, etc.) Job Offer * Competitive salaries and benefits * Great work life balance * International working environment * Hybrid working style * Amazing career progression in CMC RA * Work with industry leaders who are solving various 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 pharmaceutical companies in the industry * Rich development pipeline specialising in rare disease and orphan drugs for various unmet medical needs * Global working environment with extensive global collaboration * Patient-centric organisation delivering cutting-edge and innovative products * 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 1300万円〜 1600万円