Regulatory Project Manager

Are you passionate about navigating the complex world of regulatory affairs? Do you have the expertise to drive regulatory strategies and secure approvals that make a difference in patients’ lives? If so, we invite you to join our team as a Regulatory Project Manager in Tokyo. Read on and apply today for a life-changing career!

About the department

Novo Nordisk is a global healthcare company with over 100 years of innovation in diabetes care. This heritage has equipped us to help people defeat obesity, haemophilia, growth disorders, and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs over 77,000 people in 80 offices and markets our products in more than 170 countries.

You will be part of the Strategic Development Regulatory Affairs Department, based in Tokyo. Our team is dedicated to the development, submission, and approval of new drugs, as well as the maintenance of marketing authorisations for existing products. We pride ourselves on generating high-quality documentation that aligns with local regulatory requirements and global standards. The department fosters a collaborative and inclusive atmosphere, where team members support and inspire one another to achieve excellence. With a strong focus on professional growth, we are committed to developing our team members and shaping the future of regulatory affairs.

The position

As a Regulatory Project Manager, you will :

• Facilitate project development as a Regulatory Project Manager and member of the Global Regulatory Project Team (GRPT), preparing strategic plans aligned with Novo Nordisk's business demands.
• Provide regulatory intelligence, including updates on guidelines and regulations, to global and local team members.
• Submit high-quality applications for product authorization to achieve rapid approvals with targeted labeling and prepare documents for consultations and other regulatory submissions.
• Effectively interact with regulatory authorities to obtain and maintain marketing authorizations, optimizing the filing and approval processes.
• Coach and support team members in developing their competencies while collaborating with cross-functional teams to address project-related issues and enhance regulatory processes.

Qualifications