Manager, GPRM Japan

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。

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

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.

8億人以上の患者さんに世界中で届けられています。

10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。

https : / / www.novartis.co.jp

Japan

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 midcareer.japan@novartis.com and let us know the nature of your request and your contact

information. Please include the job requisition number in your message.

midcareer-r.japan@novartis.com