Regulatory Affairs Labelling Lead at Global Bio-Pharma

更新日 2022-05-10
掲載開始日 2022-05-10

人材紹介
スタッフレベル

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 - 生産技術/生産管理メディカル/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	Reporting to the Head of RA in Japan, lead in the RA strategy in labelling for company products. Provide any oversight in the Japanese market in regulatory development. Description * Be part of the regulatory strategic decision making process for company's TA portfolio * Partner with cross functioning departments to align product portfolio * Communicate with external stakeholders to develop an effective local plan in the Japan market * Take lead in the labelling assignments that can be accepted with Japan regulatory bodies and agencies * Be the point of contact in PMDA, MHLW discussions, consultations, negotiations Profile * University degree in life sciences or related field (pharmacist license is preferable) * Industry experience in regulatory affairs * Expertise in RA processes, regulations, and maintaining market authorisations * Experience in interacting, negotiating with regulatory bodies and able to develop relationships * Strong knowledge in drug developments and regulatory policies * Understanding of GMP, GLP, GCP, GVP, and other GxPs * High fluency in English and Japanese (non-native level speakers will not be selected) Job Offer * Competitive salary and benefits * International start-up environment * Opportunity to be part of the business decision processes and being an influence * Great work life balance * Amazing career progression in RA * Work with industry leaders who are solving unmet medical needs To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Zach Itozu on +813 6832 8683.
企業について（社風など）	* Start-up bio-pharmaceutical company with several products set to launch into Japan * Specialising in rare diseases and orphan drugs within immunology, oncology, immuno-oncology * Prides in innovation and dynamic practices for patient-centric needs * Globalised working environment with a target to support various unmet medical demand
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 800万円〜 1200万円