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東京都の臨床開発・薬事の求人158件応募資格・募集要項・仕事内容を見る
Labeling & Regulatory Affairs
- 給与
- 記載なし
- 勤務地
- 東京都
- 休日
- 記載なし
- 雇用形態
- 記載なし
どんな仕事かAIによる生成
Contribute to developing valuable new drugs and business continuity by providing and implementing optimal/valuable labeling and regulatory strategy in order to achieve BMSKK business target. The role covers labeling strategy through development and approval review, support for global applications, and post-marketing applications and labeling updates. It also includes regulatory checks of product packaging materials, advice on promotional information materials, and coaching and support for staff.
この求人に応募
応募資格
必須
- Specialized scientific knowledge and knowledge of R&D process
- Latest regulatory related knowledge (Pharmaceuticals and Medical Devices Law, ministerial ordinance, guidelines, etc.) and experience of regulatory related work.
- Knowledge of local and global organization and its role which is related to labeling and mature products
- Leadership skills
- Communication and teamwork skills
- Results orientation
- Strategic negotiation skills
- Problem-solving ability
- Analytical thinking
- Facilitation skills
- Capacity to environmental changes (external/internal)
- Enables to assign tasks to priority orders and handle a plurality of important projects simultaneously
- English communication skills (Can attend audio conference with global teams, lead the meeting, explain requirements in Japan, and obtain agreement by him/herself.)
- English communication skill for e-mail
募集要項最終確認 10/21
- 職種
- 臨床開発・薬事
- 雇用形態
- 記載なし
- 役職
- Senior Manager
- 給与
- 記載なし
- 勤務地
- 東京都
- 働き方
- 記載なし
- 掲載日
- 2026/10/12 08:00（10日前）
- 最終確認
- 2026/10/21 15:47（1日前）
仕事内容
Description
- Contribute to developing valuable new drugs and business continuity by providing and implementing optimal/valuable labeling and regulatory strategy in order to achieve BMSKK business target. For that objective, execute the following tasks;
- Have a deep knowledge of up-to-date labeling related information and finalize the highly valued labeling through providing and implementing appropriate labeling strategy in each stage of development, preparation of applications, and approval review by exerting the high expertise and teamwork.
- Provide necessary support (CPP, etc.) in order to utilize information regarding the approvals and labeling in Japan for global applications.
- Submit appropriate post-marketing applications, notifications (approval applications without clinical/CMC data, transfer of approvals, and approval withdrawals) and labeling update for all products including mature products of which contents meet the regulatory requirements by exerting the high expertise and teamwork depend on scientific knowledge and regulatory experience.
- Conduct checks based on the regulatory affairs regarding the product packaging materials.
- Offer suggestions regarding the information providing materials such as promotions, etc. from the viewpoints of the labeling and its interpretation or communication with regulatory authorities up to approvals.
Roles & responsibilities
- Perform following roles and take responsibilities. In addition, confirm that staffs fulfill the following roles properly, and provide them necessary support after sharing all staffs’ responsibilities.
- Engage internal and external stakeholders to lead to resolve and to coordinate issues in relation to the work undertaken by the project or department.
Development Stage
- Prepare a draft of target labeling while referring protocols and labeling of competing products.
- Obtain agreement for the target labeling from stakeholders in cooperation with the Regulatory Strategy Lead.
Approval Application/ Review Stage
- Contribute to the optimal labeling strategy.
- Prepare the best labeling draft after assessing up-to-date information, problems, and risks, and sharing the information with stakeholders.
- Obtain agreement for the final draft labeling from stakeholders such as Development team, Global, Marketing, or Senior management, etc.
- Consider the scenario regarding the possibility of acceptance of regulatory authorities and enhance predictability by providing options (solutions).
Support for Global Applications (Provision of CPP, etc.)
- Regarding the requirements for the global application strategy, obtain global agreement on the possible support to align with regulatory in Japan.
- Prepare necessary documents in order to obtain CPP, etc., and carry out procedures with the regulatory authorities/ embassies of various nations.
Maintenance of Marketed Products
- Submit post-marketing applications and notifications (approval applications without clinical/CMC data, transfer of approvals, and approval withdrawals).
- As for the approval applications without clinical/CMC data, examine evidence and propose a preparation method of application documents by him/herself.
- Cooperate with global teams and submit query responses in order to obtain approvals in a proper period.
- If necessary, cooperate with the Global Labeling team and contribute to revisions of labeling, and ensuring compliance.
- Lead the labeling strategy with cross-functional teams.
Advice, etc. based on the regulatory affairs
- Conduct checks based on the regulatory affairs regarding the product packaging materials and contribute to ensuring compliance in cooperation with the GPS department.
- Offer suggestions regarding the information providing materials such as promotions, etc. from the viewpoints of the labeling and its interpretation or communication with regulatory authorities up to approvals
Coaching and training of staffs
- Support colleagues and if necessary, negotiate and solve problems.
Building and improving the organization
- Understand the policies of the company and organization, play a role in their implementation.
- Leads the formulation and improvement of processes to facilitate inter-organizational cooperation.
この求人は、ブリストル・マイヤーズ スクイブ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
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応募はブリストル・マイヤーズ スクイブ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。
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- 英語14,851
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