Mgr, Regulatory Affairs

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

【職務概要 / Role Overview】

製品のライフサイクル全体を通じて、規制要件を満たすための戦略を策定し、実行する。

国内外の規制機関とのコミュニケーションを担当し、製品の承認プロセスを円滑に進めるための役割を果たす。また、社内のクロスファンクショナルチームと連携し、製品開発、製造、品質管理における規制上の課題を解決するためのサポートを提供する。
優れたコミュニケーション能力と問題解決能力により、規制の変化に迅速に対応するとともに、業界の最新動向を常に把握し、規制の更新に関する情報を社内に提供する。

1. 規制要件を満たすための戦略を策定し、実行する。
2. 国内外の規制機関とのコミュニケーションを担当する。
3. 製品の承認プロセスを管理し、円滑に進める。
4. 社内のクロスファンクショナルチームと連携する。
5. 規制の更新に関する情報を社内に提供する。
6. 製品開発、製造、品質管理における規制上の課題を解決する。
7. 業界の最新動向を常に把握する。
8. 規制の変化に迅速に対応する。

Develop and execute strategies to meet regulatory requirements throughout the product lifecycle.
Responsible for communication with domestic and international regulatory agencies and plays a role in facilitating the product approval process. Also, work with cross-functional teams within the company to provide support in resolving regulatory issues in product development, manufacturing, and quality control.
With excellent communication and problem-solving skills, you will be able to respond quickly to regulatory changes, stay up-to-date on the latest industry trends, and provide information on regulatory updates within the company.
1. Develop and execute strategies to meet regulatory requirements.
2. Responsible for communication with domestic and international regulatory agencies.
3. Manage and facilitate the product approval process.
4. Work with cross-functional teams within the company.
5. Provide information on regulatory updates within the company.
6. Resolve regulatory issues in product development, manufacturing, and quality control.

7. Stay up-to-date on the latest industry trends.
8. Respond quickly to regulatory changes.

【職務内容 / Key Responsibilities】

1. 戦略薬事
2. 開発薬事
3. 薬制薬事
4. CMC薬事
5. 薬事申請（薬事資料作成、）
6. 電子申請／申請マネジメント
7. 薬事資料作成
8. 添付文書／ラベリング
9. マネジャー業務

1. Strategic Regulatory Affairs
2. Development Regulatory Affairs
3. Development Regulatory Affairs
4. CMC Regulatory Affairs
5. Regulatory Application
6. Electronic Application/Application Management
7. Writing and File preparation
8. Package Inserts/Labeling
9. Managerial Duties

【求められる経験・スキル・知識 / Qualifications ・ Education ・ Experiences】

1. 経験:
・薬事関連の経験:5年以上
・医薬品業界での薬事経験:３年以上
・国内外の規制機関との交渉経験
・クロスファンクショナルチームでの作業経験
・チームマネジメント経験
2. スキル:
・優れたコミュニケーション能力と問題解決能力
・規制の変化に迅速に対応できる柔軟性
・業界の最新動向を常に把握し、社内に落とし込む能力
・一般的に定義された方針の範囲内で、独立した意思決定と分析的思考スキルを発揮して複雑な問題解決／Project management skill
・柔軟性と適応性に基づく、Conflict management skill
・プレッシャーの下で独立して作業し、複数のタスクのPriority settingする能力
・Leadershipを発揮、影響を与え、チーム内で他の人をサポートする能力
・人財管理に関する優れたOrganizational skill
・国内外のStakeholderとのCommunication skill
3. 学位及び資格:
・薬剤師（望ましい）
・TOEIC 800 相当以上
・MS Excel/Word エキスパートと同等/

1. Experience:
・Regulatory experience: 5 years or more
・Regulatory experience in the pharmaceutical industry: 3 years or more
・Experience in negotiations with domestic and international regulatory agencies
・Experience working in a cross-functional team
・Team management experience
2. Skills:
・Excellent communication and problem-solving skills
・Flexibility to quickly respond to regulatory changes
・Ability to keep up with the latest industry trends and incorporate them within the company
・Complex problem-solving/project management skills by demonstrating independent decisionmaking
and analytical thinking skills within a generally defined policy
・Conflict management skills based on flexibility and adaptability
・Ability to work independently under pressure and prioritize multiple tasks
・Ability to demonstrate leadership, influence and support others within a team
・Excellent organizational skills in human resource management
・Communication skills with domestic and international stakeholders
3. Degrees and qualifications
・Pharmacist (Preferable)
・TOEIC 800 equivalent or higher
・Equivalent to MS Excel/Word Expert

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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