Jun 02, 2022

Job Description

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。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
- 社内外や規制当局も巻き込んで、AIやITテクノロジーを活用した先進的な医薬品開発を推進していくイノベーティブな活動にも参画できる

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 with obtaining support from GPRM-J/Head of RAU-J.
2. Contribute to the regulatory activities in day-to-day operations for assigned TA area with obtaining support from GPRM-J/Head of RAU-J.
3. Lead cross functional communication for preparing and finalizing Japanese labeling for new drugs with obtaining support from GPRM-J/Head of RAU-J..
4. Take regulatory related actions to maintain post marketing products in Japan with obtaining support from GPRM-J/Head of RAU-J..
5. Establish goodrelationship with the Japanese HA in responsible projects with obtaining support from GPRM-J/Head of RAU-J.
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.

Diversity & Inclusion / EEO

Novartis is 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.
Global Drug Development
Research & Development
Full Time
careers default image

Associate, GPRM Japan

Apply to Job Access Job Account