職種・勤務地・キーワードで探す
条件を変える
大阪府の臨床開発・薬事の求人60件応募資格・募集要項・仕事内容を見る
Japan Regulatory Affairs (RA) CMC, Plasma Derived Therapies (PDT)
- 給与
- 記載なし
- 勤務地
- 大阪府
- 休日
- 年間休日123日
- 雇用形態
- 正社員
- ハイブリッド勤務
- 在宅勤務あり
- 年間休日120日以上
- 賞与あり
- 退職金あり
どんな仕事かAIによる生成
Japan Regulatory Affairs CMC, PDTの代表として、血漿分画製剤の開発・ライフサイクル管理におけるCMC規制対応、申請戦略の策定・実行を担います。社内外の関係者や規制当局との連携に加え、グループの人材育成、組織運営、予算・人員管理を支援します。
この求人に応募
応募資格
必須
- Executive knowledge of regulations and CMC technology of one or more types of products, such as plasma-derived products, biologics, small molecule, regenerative medicine, cell therapy products, etc.
- Knowledge of manufacturing and/or analytical testing of investigational/commercial products (experiences are preferred)
- Experiences of negotiation and communication with the Japanese regulatory agency (PMDA / MHLW).
- Good communication capability with various stakeholders in Japan and foreign countries
歓迎
- People management experiences preferred
- Fluent English language skill is desired in oral and written commutation (e.g. TOEIC: greater than 750 points).
募集要項最終確認 10/15
- 職種
- 臨床開発・薬事
- 雇用形態
- EmployeeRegularFull time
- 役職
- Associate Director
- 給与
- 記載なし
- 給与の詳細
- Salary Increase: Annually, Bonus Payment: Twice a year
- 手当
- CommutationHousingOvertime Work
- 勤務地
- Osaka, JapanTokyo, Japan
- 働き方
- Flexible Work Styles: Flextime, Telework
- 勤務時間
- Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30
- 年間休日
- 123日
- 休日・休暇
- SaturdaysSundaysNational HolidaysMay DayYear-End Holidays etc. (approx. 123 days in a year)Annual Paid LeaveSpecial Paid LeaveSick LeaveFamily Support LeaveMaternity LeaveChildcare LeaveFamily Nursing Leave
- 福利厚生
- Flexible Work Styles: Flextime, TeleworkRetirement and Corporate PensionEmployee Stock Ownership Program, etc.
- 社会保険
- Social Insurance
- 業務の変更の範囲
- It is possible the job scope may change at the company’s discretion.
- 就業場所の変更の範囲
- It is possible the department and workplace may change at the company’s discretion.
- 学歴
- 大学院修了以上
- 掲載日
- 2026/10/11 11:07（5日前）
- 最終確認
- 2026/10/15 09:15（1日前）
仕事内容
OBJECTIVES/PURPOSE
- Act as a representative of Japan Regulatory Affairs CMC, PDT in a cross-functional team to proceed with development and lifecycle management for plasma-derived products.
- Responsible for regulatory CMC development, registration and post-approval strategies and plans for J-NDA of the assigned products throughout clinical development and commercial lifecycle. Ensures global strategies of the assigned products are successfully executed across both new product development and existing portfolio life cycle management.
- Successfully communicates and negotiates with Health Authorities as necessary, directly and indirectly to execute the strategy and plan for the assigned products.
- Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.
- Demonstrates leadership and comprehensive understanding of RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.
- Develop people in Japan Regulatory Affairs CMC, PDT, and support resource planning and organizational management.
ACCOUNTABILITIES
- Have responsibility for the deliverables by performing the following roles expected for the assigned projects with minimal supervision:
- Plan and create CMC part of dossier throughout development, new drug application (NDA) and post-approval variation submissions according to agreed project timeline. (CTD M1.2, M2.3, queries and responses, partial change application (PCA), minor change notification (MCN), consultations, etc.).
- Pre-approval GMP compliance inspection and accreditation of sites for NDA and PCA.
- Periodic GMP compliance inspection and renewal of accreditation of foreign manufacturing sites.
- Collaborate and build relationships with counterparts in internal and external divisions/departments, regulatory authorities, etc. in order to fulfill the roles for above.
- Contribute to develop strategies and manage the organization of Japan Regulatory Affairs CMC, PDT, including appropriate personnel composition within the group and acquisition of knowledge and experience necessary to demonstrate high performance in the environment anticipated in the future, looking ahead the future direction of drug development, regulatory environment, etc.
- Talent development within the group and proposing human resources from inside and outside the company
- Support the Director for his/her management of budget and headcount of the group.
CORE ELEMENTS RELATED TO THIS ROLE
- Responsible for the success of Japan Regulatory Affairs CMC, PDT (A sense of responsibility and a strong will)
- Collaborate and build relationships with counterparts of internal global organizations, competitors in the same industry, and regulatory authorities (Requires high interpersonal negotiation skills).
- Contribute to strategizing and executing the organization's operations from a long-term perspective (Include strategies for utilizing internal and external resources) (Requires logical thinking and ability to take action)
- Contribute to managing group’s budget and headcount (Knowledge and experience of organization operation)
Technical/Functional (Line) Expertise
- Knowledge and experiences of CMC technology for pharmaceutical products (plasma-derived products, chemical synthesis, biologics, cell therapy, medical devices including software, etc.)
- Knowledge and experiences of GMP-related operations.
- Knowledge of regulations (Japan/Overseas), knowledge of regulatory trends
- Level of expertise is expected to be able to discuss contents of submission dossier (Module 3) of the assigned projects with SMEs (Subject Matter Experts) in internal/external organizations and regulatory authorities.
Leadership
- Set a good example to lead peers in Japan Regulatory Affairs CMC, PDT.
- Gain cooperation from relevant organizations (PS, GQS, GRA, etc.) [1-Level or 2-Level upper]
- Improve performance of peers in Japan Regulatory Affairs CMC, PDT by energizing members.
- Plan and execute talent development of peers in Japan Regulatory Affairs CMC, PDT.
Interaction
- Demonstrates the cooperation, collaboration, and involvement required for communication among people in charge (e.g. equivalent position), and draws the commitment of others through diverse communication. Build and influence internal and external relationships (e.g. escalation to 1-level upper).
- Coordinating ability to communicate ideas to, understand, and align interests with counterparts of relevant organizations.
- Perform a strategic approach to counterparts and stakeholders to get their cooperation based on mutual understandings.
Innovation
- Strategic thinking around potential impact on projects (including non-clinical and clinical), exceeding the scope of Japan RA CMC area.
- Contribute to plan and lead changes of Japan Regulatory Affairs CMC, PDT (organization structure, talents, outsourcing, etc.) to improve performance from the mid- to long-term perspectives.
Complexity
- High challenge complexity and impact (department/group level)
- Raise their own problems (Zero-base), develop hypotheses for resolution, and propose and implement solutions.
- Contribute to propose and execute changes considering future trend without basis of past examples or evidences.
- Learn and adopt new technology areas of the assigned projects within short period
Decision-making and Autonomy
- Determine and execute the direction/strategy of peers in Japan Regulatory Affairs CMC, PDT for which he/she is in charge, responses to regulatory authorities, and collaboration with Global.
- Support to determine assignment of projects, priority, delegation, resource allocation, budget, etc. within the group.
この求人は、武田薬品工業株式会社の採用ページの内容をAIが読み取って整理したものです。応募の前に採用ページの原文を確かめてください。データの集め方企業サイト
同じ会社の求人61件
- Head of Characterization Small Molecules, R&D
- Associate Medical Director, Oncology Clinical Sciences, R&D
- Principal Scientist, Parenteral DP, Drug Product and Device Development
- SC室 倉庫担当者
- 注射剤検査・包装担当者
- 化学プロセス／生産技術・設備設計エンジニア
職種と勤務地が似ている求人大阪府の臨床開発・薬事 60件
- メディカルアフェアーズ 専門マネージャー
- Associate Medical Director, Oncology Clinical Sciences, R&D
- 臨床開発モニター
- 開発薬事シニアコンサルタント（医薬品開発・承認申請支援/コンサルティング）
- 経験者モニター（CRA）
- クリニカルリーダー
募集元の採用ページから応募できます
応募は武田薬品工業株式会社の採用ページで受け付けています。このページは採用ページの掲載内容をもとに構成しているため、最新の応募条件は募集元でご確認ください。
この求人と近い条件で探す数字はリンク先ページの掲載件数
応募資格の語から探す
- 英語13,220
この職種で探す
- 臨床開発・薬事307
- 大阪府の臨床開発・薬事60
- 医療職3,274
- 薬剤師949
- 児童指導員・生活支援員634
この勤務地で探す
働き方・年収で探す
- 年収400万以上37,934
- 在宅勤務あり21,305
- 年間休日120日以上35,417
- 賞与あり36,044
- 退職金あり32,774