更新日 2025-03-14
掲載開始日 2025-03-14

CMC RA Manager at Global Regulatory Consulting (Fully Remote)

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 for client needs on various projects. Lead the CMC RA Team. Description * Take lead in RA CMC strategy for company client's for various projects * Lead the CMC RA department * Develop CMC RA planning in terms of any change control activities, submissions, communication with the local health authorities (PMDA, MHLW) etc. * Lead proper registration for client's facilties for FMA * Execute regulatory strategies to align client's strategies * Prepare in CTD documents to support in JNDA applications as well as any post-marketing activities Profile * University degree in scientific or related field * High fluency in English and Japanese (non-native level speakers will not be selected) * CMC RA experience in the pharmaceutical industry with track record of product approval * Strong understanding of local regulations CTD requirements * Ability to communicate with local health authorities as well as with global stakeholder/clients * People management experience Job Offer * Competitive salaries and benefits * Great work life balance * Fully remote option * Amazing career progression in CMC RA * Work with industry leaders who are solving various unmet medical needs * International working environment To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Saki Kanematsu at +81 3 6832 8904.
企業について（社風など）	* Global Regulatory/Quality consulting company specialising in the pharmaceutical, medical device, cosmetic areas * Rich project pipeline working with some of the top health care companies in the industry to support in regulatory and quality activities * Japan business grew exponentially within the past 5 years due to demand * Fully remote * International environment with extensive global collaboration
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 1500万円〜 1800万円