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Vice President, Regulatory Affairs Japan

年収：1800万～ 3000万

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部署・役職名	Vice President, Regulatory Affairs Japan
職種	非臨床研究臨床開発薬事
業種	医薬品メーカー
勤務地	大阪府
仕事内容	OBJECTIVES/PURPOSE As a member of the Global Regulatory Affairs leadership team, contributes to the vision and goals of Global Regulatory Affairs (GRA) and ensures that Global Regulatory Affairs (GRA-J) Japan objectives are aligned with those. As a member of Takeda Development Center Japan (TDC-J) leadership team, creates the environment that enables TDC-J members to drive clinical programs and other initiatives in TDC-J. Collaborates and aligns with GRA as appropriate and acts as the GRA Japan entire representative where the incumbent is located. Provides leadership, strategic direction, and managerial oversight to GRA Japan team to develop and execute regulatory strategies and plans for Japan region. Work as a leadership position among regulatory related functions in Japan to support them in engagement, career development, and talent management. ACCOUNTABILITIES Develop organizational vision and goals and build an organization accordingly by acquiring necessity talents and capabilities. Provide mindsets and expertise based on vision, value, Takeda-ism in RA Japan to ensure that emerging trends/issues are addressed by utilizing creative problem-solving skills, and proactively influencing GRA. Drive business with GRA LT and TDC-J LT to realize vision, strategies, and goals in GRA, TDC-J as well as Takeda. Manage and supervise regulatory activities in Japan including development of processes to ensure efficient and timely registration of development products and maintenance of marketed ones. Ensure regulatory submissions with high quality and timely manners. Ensure full compliance with government regulations and corporate policies by promoting compliance policies. Develop and maintain comprehensive and strong partnering relationships with health authorities in Japan as well as internal division heads. Support RA Japan members in negotiating with regulatory authorities to achieve positive outcomes to Takeda. Ensure that key regulatory requirements and commitments in Japan are brought to the attention of senior managements, such as GRA head, TDC-J head etc. Elevate the capabilities of the organization and talent in GRA Japan from the mid- to long-term perspective, e.g., through talent development and securing human resources from inside and outside the company. Make the most of resources (budget and headcount) in GRA Japan to achieve the vision and goals. CORE ELEMENTS RELATED TO THIS ROLE Responsible for Global Regulatory Affairs Japan as a whole (A sense of responsibility and a strong will) Collaborate and build relationships with executives of internal global organizations, high level RA managements in other pharmaceutical companies, and directors in regulatory authorities (Requires high interpersonal negotiation skills) Strategizing and executing the organization's management from a long-term perspective (Include strategies for utilizing internal and external resources) (Requires logical thinking and ability to act) Manage budget and headcount in GRA Japan (Knowledge and experience of organization operation) Consider the future of GRA Japan organization (including vision, goal etc.) and practice to achieve it. Introduce new initiatives to activate GRA Japan organization in collaboration with internal and external stakeholders.
応募資格	【必須（MUST）】 At least 10 years experiences in Regulatory Affairs, supported by additional pharmaceutical / industry experiences. Extensive experiences in a senior level in Regulatory Affairs, Quality, or other relevant legislation and processes (PMDA, FDA, EMA). General Management experiences with line management and leadership at senior management level. Demonstrable experiences of effective delivery of objectives in complex matrix environments. Negotiation and communication skills with high-level management in regulatory authorities. Communication skills beyond cultures. 【歓迎（WANT）】 A degree in MSc (mandate), or Ph.D. (preferred) in life science area, such as Biological, Medical Science, Pharmacy etc.
アピールポイント	自社サービス・製品あり日系グローバル企業女性管理職実績あり上場企業従業員数1000人以上創立30年以上年間休日120日以上産休・育休取得実績ありストックオプション制度あり教育・研修制度充実資格支援制度充実 Uターン・Iターン歓迎フレックスタイム
リモートワーク	可「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります
受動喫煙対策	屋内禁煙
更新日	2025/11/20
求人番号	4825043

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武田薬品工業株式会社

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