Regulatory Project Manager

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. QualificationsBachelor'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 NordiskWe 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.