Global Program Regulatory Manager Japan

Updated: 3 months ago
Location: Japan,
Deadline: 07 Sep 2023

Job Description

Job Purpose:
Contribute to the overall activities in drug development* toward obtaining the marketing authorization and maintenance activities of post marketing products in assigned TA.
* Drug development including development of drug, medical device, companion diagnostics and tissue-engineered medical products

Global Program Regulatory Manager (GPRM) Japanの業務には,以下の醍醐味,やりがいがあります.
医薬品の初期開発段階からプロジェクトチームに参画し,承認取得までの期間を通し,薬事戦略の立案やそれに基づく開発プランの作成,規制当局(MHLW, PMDA)との折衝,Globalと協働しながら世界同時開発,申請/承認をドライブしていくことに興味のある方,ぜひご応募ください.

- 開発早期から承認取得,市販後まで薬の一生に幅広く関わることができる
- 規制や業界の流れを正しく読み取り,将来的な変化を見越した薬事戦略の立案/実行をリードできる
- 社内外の顧客や海外の開発関連部署など多くのメンバーと多岐にわたる仕事に携われる
- 個人としての作業に加えて,チームメンバーとの協働を通じて,申請•承認などの大きなマイルストーンも経験できる
- 社外の業界活動に参画し規制当局も巻き込み先進的な医薬品開発を推進していく積極的な活動にも貢献できる

Major Accountabilities:
1. Assist developing innovative and high quality regulatory strategies to facilitate regulatory processes in development and ensure registration with optimized labels that contribute to health and welfare of the Japanese nation.
2. Contribute to the regulatory activities in day-to-day operations for assigned TA area.
3. Lead cross functional communication for preparing and finalizing Japanese labeling for new drugs.
4. Take regulatory related actions to maintain post marketing products in Japan.
5. Establish goodrelationship with the Japanese HA in responsible projects
6. Contribute to the adherence to regulations, guidelines and global/internal procedures.
7. Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
8. 100% timely delivery of all training requirements including compliance

Why consider Novartis?

817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.


Novartis is committed to working with and providing reasonable accommodation to
individuals with disabilities. If, because of a medical condition or disability, you need a
reasonable accommodation for any part of the recruitment process, or in order to
perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact
information. Please include the job requisition number in your message.
必須事項を果たすために合理的配慮が必要な場合は [email protected]

Diversity & Inclusion / EEO

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Degree in pharmacy, medicines, science, agriculture and/or pharmaceutical engineering discipline required. Advanced degree (Master Degree, PhD, etc.) prefered.
• Pharmacist license preferred.

Experience/Professional requirement:
1. Demonstrate good presentation skills in delivering clear messages to audience and modifying language and style to meet the needs from audience.
2. Understand the drug development/maintenance processes, milestones in the assigned disease area and Novartis procedures for decision board review and approval.
3. Understand basic knowledge of Japan regulation
4. Possess basic knowledge of global regulatory environment, and contribute to elaborating the project specific development/regulatory strategy and plan.
5. Report and summarize discussions in which RA plays an important role.
6. Good in writing and reading English (e.g. exchange of scientific and technical information by e-mail and generation of scientific and technical documentation).
7. Proactively communicate issues and potential solutions.
8. Provide updates on current situation, and ensure that the same information is disseminated throughout the organization as needed.
9. Network with others and share information.
10. Demonstrate cultural awareness and work in cross cultural environment.

English Skill:
Fluent English as business language.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our
people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

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