Senior Specialist, Labeling & Regulatory Affairs

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. 概要 (High-level Description; including manage team/individuals or not) BMSKKのビジネスターゲットを達成するために、最適な添付文書・薬事戦略を立案・実行することにより、価値の高い新薬開発及びビジネスの継続に貢献する。そのために、以下を行う。 最新の添付文書関連情報に精通し、開発計画、申請準備、承認審査のそれぞれの段階で、高い専門性とチームワークにより、最適な添付文書戦略を立案・実行し、価値の高い添付文書を最終化する。 日本の承認、添付文書情報をグローバルの申請に利用するために必要なサポート（CPP等の提供）を行う。 科学的知識及び薬事的経験に裏打ちされた高い専門性とチームワークにより、マチュアプロダクト（既存品）を含む全製品における日本の規制要件を満たした最適な製造販売後の申請・届出（臨床/CMCデータを伴わない承認申請、承継、承認整理等）及び添付文書改訂を行う。 製品の包装資材において、薬事関連規制に基づいた助言を行う。 プロモーション等情報提供資材において、添付文書とその解釈あるいは承認に至るまでの当局とのやりとりの観点から助言を行う。 役割 (Roles & responsibilities) 以下の役割を上位者のアドバイスを受けながら実行する。 開発計画段階： プロトコール、競合品の添付文書等を参照し、Target labeling案を作成する。 レギュラトリー・ストラテジー リードと連携して、Target labelingについて、ステークホルダーの合意を得る。 申請準備・承認審査段階： 最適な添付文書戦略に貢献する。 最新情報や問題点・リスクを評価し、ステークホルダーと共有した上で、ベストな添付文書案を作成する。 開発チーム、グローバル、マーケティング、PV、メディカル、また、シニアマネージメント等のステークホルダーから添付文書最終案に対して合意を得る。 当局受け入れ可能性についてScenarioを検討し、オプション（解決策）を示すことで予見性を高める。 グローバルの申請サポート（CPP等の提供）： グローバルの申請ストラテジーの要求事項に対し、日本の規制上、可能なサポートについて合意を得る。 CPP等取得に必要な資料を作成し、当局あるいは各国大使館と手続きを行う。 既存品のメンテナンス： 製造販売後の申請・届出（臨床/CMCデータを伴わない承認申請、承継、承認整理等）を行う。 臨床/CMCデータを伴わない承認申請においては、エビデンスを精査し、申請資料のまとめ方等を自ら考える。 グローバルと連携して、当局からの照会事項に回答し、適切な時期に承認を取得する。 必要に応じてGlobal Labeling teamと協力して、添付文書改訂、コンプライアンスの確保に貢献する。 Cross functional teamにおいて添付文書戦略をリードする。 薬事関連規制に基づいた助言等： 製品の包装資材において、薬事関連規制に基づいた助言等を行う。 プロモーション等情報提供資材において、添付文書とその解釈あるいは承認に至るまでの当局とのやりとりの観点から助言を行う。 必要な知識/スキル (Required knowledge/skills) 以下の知識/スキルが備わる。 科学的専門知識と研究開発プロセスに関する知識がある。 最新の薬事関連知識（薬機法、省令、ガイドライン等）があり、薬事関連業務の経験がある。 ラベリング、マチュアプロダクトに関連するローカル及びグローバルの組織とその役割に関する知識がある。 コミュニケーション能力とチームワークを発揮できる。 結果思考である。 戦略的交渉能力がある。 問題解決能力がある。 分析思考である。 外部環境・内部環境の変化への適応がある。 １つの重要なプロジェクトを担当できる。 グローバルと電話会議で1対1であれば議論をマネージできる英語力がある。 メールにて英語でのコミュニケーションができる。 xxxxx High-level Description; including manage team/individuals or not In order to achieve BMSKK's business targets, we will contribute to the development of high-value new drugs and business continuity by planning and executing optimal package inserts and regulatory strategies. To do so: We are familiar with the latest information related to package inserts, and at each stage of development planning, application preparation, and approval review, we plan and execute optimal package insert strategies with high expertise and teamwork, and finalize high-value package inserts. become We will provide necessary support (provide CPP, etc.) to use Japanese approval and package insert information for global applications. With high expertise and teamwork backed by scientific knowledge and regulatory experience, we provide optimal post-marketing applications and notifications (clinical/CMC) that meet Japanese regulatory requirements for all products, including mature products (existing products). Approval application without data, succession, approval arrangement, etc.) and package insert revision. Provide advice based on pharmaceutical affairs regulations regarding product packaging materials. Provide advice on information provision materials such as promotions from the perspective of package inserts and their interpretation or interaction with authorities until approval. Roles & responsibilities Perform the following roles while receiving advice from superiors. Development planning stage: Create a target labeling plan by referring to the protocol, package inserts of competing products, etc. Work with the Regulatory Strategy Lead to get stakeholder consensus on Target labeling. Application preparation/approval review stage: Contribute to an optimal package insert strategy. Evaluate the latest information, problems, and risks, share them with stakeholders, and create the best package insert draft. Obtain agreement on the final package insert from stakeholders such as the development team, global, marketing, PV, medical, and senior management. Consider scenarios for the possibility of acceptance by the authorities, and improve predictability by presenting options (solutions). Global application support (providing CPP, etc.): Obtain agreement on possible regulatory support in Japan for the requirements of the global application strategy. Prepare materials necessary for obtaining CPP, etc., and carry out procedures with the authorities or embassies of each country. Maintenance of existing products: Post-marketing applications/notifications (applications for approval without clinical/CMC data, succession, approval review, etc.). When applying for approval without clinical/CMC data, carefully examine the evidence and think about how to compile the application data. Collaborate with Global to respond to regulatory inquiries and obtain approvals in a timely manner. Cooperate with the Global Labeling team as necessary to revise package inserts and contribute to ensuring compliance. Lead the package insert strategy in the cross functional team. Advice based on pharmaceutical regulations: Provide advice based on pharmaceutical affairs regulations regarding product packaging materials. Provide advice on information provision materials such as promotions from the perspective of package inserts and their interpretation or interaction with authorities until approval. Required knowledge/skills Has scientific expertise and knowledge of the R&D process. Has the latest pharmaceutical knowledge (Pharmaceuticals and Medical Devices Act, ministerial ordinances, guidelines, etc.) and has experience in pharmaceutical affairs. Knowledge of local and global organizations and their roles related to labeling and mature products. Able to demonstrate communication skills and teamwork. It is result thinking. Ability to negotiate strategically. have problem-solving ability. Analytical thinking. Adapts to changes in external and internal environments. You can take charge of one important project. He has the English ability to manage one-on-one discussions with global teleconferences. Able to communicate in English by e-mail. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. 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