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| 部署・役職名 | 【柔軟的な勤務形態・少数精鋭チーム】薬事グループマネージャー |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
Basic Purpose of the Job: The Head of Development Regulatory Affairs is responsible for developing and implementing regulatory strategies for assigned therapeutic areas. This role includes guiding subordinates on the development of investigational products towards submission and approval and coordinating regulatory maintenance activities in compliance with Japanese regulations. The role requires providing strong leadership and strategic planning to integrate sound regulatory practices into international drug development programs. Additionally, this position involves contributing to staff development in terms of expertise, competencies, and career plans, leading and guiding subordinates, assigning projects, and fulfilling human resource obligations. Key Accountabilities: － Develop and implement regulatory strategies for product development and maintenance. － Provide guidance and input on global key regulatory documents. Attend and advise on key pharmacovigilance meetings. － Prepare and manage Health Authority Interactions （HAI） and regulatory applications. － Conduct timely risk/benefit analysis of topics affecting products and projects. － Evaluate Japanese regulations and guidelines for their impact on existing procedures. － Develop therapeutic area specific regulatory intelligence for Japan. － Promote awareness of the regulatory landscape within the organization. － Support the Regulatory Intelligence Network by compiling alerts and impact assessments. － Adhere to internal compliance rules. － Monitor regulatory guideline developments and analyze their impact on compliance. － Perform regulatory tasks for products/projects with licensing partners as outlined in contracts. － Manage close external relationships with health authorities, industry associations, and license partners. － Provide regulatory strategic guidance and leadership to the Regulatory Affairs team. － Develop talent management strategies with cross functional collaboration. － Train and develop team members. － Actively participate and contribute to various business forums. － Contribute to brand team strategy and business reviews. － Plan budget and resource allocation. － Supervise managers, staff, assistants, and trainees. － Propose assignments of regulatory roles to products/projects. － Monitor goals and capacity. － Provide updates to top management and participate in decision－making committees. － Contribute to individual working groups upon special assignment. － Support the Head of Regulatory Affairs Japan with specific projects and activities. － Stimulate and encourage innovation in daily activities. － Regular interaction and dialogue with local functions such as Regulatory Affairs, Medicine, Legal, Supply, and Marketing. － Communication with global functions including Global Regulatory Affairs, Corporate Medicine, Asset Teams, and Global Quality. － Engage in dialogue and negotiations with health authorities, industry associations, and license partners as required. |
| 応募資格 |
【必須（MUST）】 Required Skills and Experience:Knowledge: － In－depth knowledge of international regulatory requirements and Japanese regulatory legislation. － Excellent understanding of internal processes and procedures. － Knowledge of drug development, marketing authorization applications, and maintenance. － Understanding of health authority environments and trends. Professional Skills: － Leadership skills to develop and implement solutions to complex problems. － International perspective and inter－cultural competence. － Open－minded, motivating personality with drive and initiative. － Ability to create and share knowledge. － Critical thinking and self－management skills, including prioritizing and delivering under tight timelines. － Ability to work well under pressure, influence without authority, and possess good interpersonal and negotiation skills. － Team player, flexible, and adaptable to change. － Excellent oral and written communication skills. Experience: － Over 5 years of experience in Regulatory Affairs, including new drug registration. － Practical experience with new developments, registrations, and maintenance of Marketing Authorizations. － Experience with direct Health Authority interactions. － Track record in filings of Clinical Trial Notifications, Marketing Authorization Applications, and related regulatory applications. － Over 5 years of management experience. － Preferably international work experience. Language Skills: － Fluent in Japanese and English. 【歓迎（WANT）】 Experience:－ Over 5 years of experience in R＆D and/or medical development. － Preferably international work experience. |
| 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 | その他 「就業場所が屋外である」、「就業場所によって対策内容が異なる」、「対策内容は採用時までに通知する」 などの場合がその他となります。面接時に詳しい内容をご確認ください |
| 更新日 | 2024/12/10 |
| 求人番号 | 4147825 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です