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

• Bachelor's degree or higher in a scientific field.
• Over 3 years of experience with the Japanese regulatory related processes in drug development, including familiarity with relevant regulations and basic scientific and medical knowledge related to the company's products.
• Strong leadership, planning, problem-solving, teamwork, and communication skills.
• Possesses a good business mindset, ethical behavior, an open mind, proactive attitude, adaptability to change, and a customer-oriented focus.
• Proficient in reading, writing, and speaking in both English and Japanese.

Working at Novo Nordisk
We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease.

Contact
Upload your CV to our online career page (click on Apply and follow the instructions).

Deadline
Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
 
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

#LI-AMS1