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Merck KGaA, Darmstadt, Germany and its affiliates · Tokyo, Japan

# Head of Regulatory Affairs Group 1（開発薬事）_ Biopharma

Tokyo, Japan Full-time Executive Legal & Compliance 

Listed on Merck KGaA, Darmstadt, Germany and its affiliates’s official careers site. Posted October 15, 2026. Check that it is still open and apply there.
[Apply on Merck KGaA, Darmstadt, Germany and its affiliates’s careers site →](https://careers.merckgroup.com/global/en/job/MQAMKDGLOBAL303687EXTERNALENGLOBAL/Head-of-Regulatory-Affairs-Group-1-Biopharma)

[OpenNash Jobs](https://jobs.opennash.com/) / [Merck KGaA, Darmstadt, Germany and its affiliates](https://jobs.opennash.com/companies/merck-kgaa-germany/) / Head of Regulatory Affairs Group 1（開発薬事）_ Biopharma

## Job description

メルクと一緒に、あなたの力を発揮しよう！ 冒険、限界への挑戦、そして発見に焦がれるあなたへ。あなたの大志を、メルクで羽ばたかせましょう！科学とテクノロジーを駆使したイノベーションに情熱を注ぐメルクのスタッフは世界中で活躍中です。ヘルスケア、生命科学、エレクトロニクスの分野で、メルクのソリューションは人々の暮らしをますます豊かなものにしています。あなたとメルクの力を合わせて、大きな夢を抱きましょう。メルクは、人、顧客、患者、そしてこの地球という惑星が共存する豊かな世界の構築に情熱を注いでいます。このためメルクでは、好奇心にあふれた人材を募集中です。メルクと一緒に、想像を超えた世界を開拓しませんか？ 患者さんのためにひとつになって団結し、生命の誕生、QOLの向上、命をつなぐサポートをすることか、ヘルスケアにおける私たちの目的です。私たちは、腫瘍学、神経学、不妊治療などの疾患領域において、医薬品、インテリジェント装置、革新的技術を開発します。

私たちのチームは、人生のすべてのステージで患者さんを助けるために、情熱と執拗な好奇心を持って6大陸全体で協力して働いています。ヘルスケアチームに入ることは、多様的で包含的、そして柔軟な職場文化の一部となることです。世界中で個人的な能力開発とキャリアアップの素晴らしいチャンスが待ち受けています。

### Head of Regulatory Affairs (開発薬事チーム) Lodation

Japan Report to: Head of Global Regulatory Affairs Japan Direct Reports: 5 Your Role: Develop and execute regulatory affairs (RA) activities from the development to the life cycle management, with collaborative with global and Japan stakeholders. Regulatory Affairs Group 1 Head focuses on the following development activities: Oversee, manage, mentor, and ensure that Group plans and delivers the regulatory deliverables as the representative of Group, while complying with applicable regulations.

Provides coaching and development opportunities to staff. Lead RA-related Health Authority (HA) interactions. e.g., PMDA or MHLW interaction Lead New Drug Application (NDA) and supplementary NDA (sNDA) such as indication expansion, new formulation, etc. Lead preparation of the Japan NDA activities and HA’s review for approval. Prepare the Japan-CTD regulatory parts such as Approval Application Form, Module 1, etc. Lead electronic Japanese Package Inserts (J-PI), respond to query, and join artwork activities.

Review promotion materials. Manage Outsourcing vendors as needed. Represent RA for the SOPs/WI updates and improvement tasks.

### Who You Are

Education and Preferable work experiences: Extensive experience and knowledge in Regulatory Affairs, especially development activity. Experiences and knowledge of Collaborating with cross-functional team and global member.

### Competencies and skills

Language: Japanese- native level.

### English

Able to communicate with global members as J-RA representative. People management skills Stakeholder management, Communication/coordination, leadership/ownership skills, strategic consideration and project/risk management skills (e.g., To Clarify regulatory risks and plan/execute minimization/mitigation).

### 私たちが提供するもの

私たちは、さまざまな背景、視点、人生経験を持つ好奇心旺盛な人々で構成されるグループです。この多様性が卓越性と革新を促進し、科学と技術のリーダーシップを強化すると信じています。私たちは、すべての人が自分のペースで成長し発展するためのアクセスと機会を創出することにコミットしています。何百万もの人々に影響を与え、誰もが人類の進歩を支持できるようにする包括性と帰属感のある文化を築くために私たちに参加してください！ 今すぐ応募して、発見を促し、人類の発展を高めることに専念するチームの一員になりましょう！

## At a glance
- Posted by the employer: Oct 15, 2026
- First seen by OpenNash: Oct 19, 2026
- Last checked: Oct 19, 2026
- Listed for: 4 days
- Location: Tokyo, Japan
- Employment type: Full-time[Apply on Merck KGaA, Darmstadt, Germany and its affiliates’s careers site →](https://careers.merckgroup.com/global/en/job/MQAMKDGLOBAL303687EXTERNALENGLOBAL/Head-of-Regulatory-Affairs-Group-1-Biopharma)

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