Department: RA GLP-1
Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to ensure the life cycle management of Novo Nordisk\xe2\x80\x99s medicines by regulatory authorities across the globe. Regulatory Affairs is a fast-changing field where no two days are alike, and the engaged employees in our unit need a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders. Apply now and join a growing team, working in an international environment.
Position As a Regulatory Professional you are expected to handle below responsibilities: -

• Become a member of cross functional project teams including study groups and submission teams and provide regulatory input within the Semaglutide department.
• Drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines e.g.: Worldwide NDA submission.
• Participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports and regulatory files for marketing authorization.
• Interact with medical and non-clinical specialists, statisticians, and medical writers. You will be closely working with our Global Regulatory Leads (GRL) on projects related to the Semaglutide portfolio.
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Qualifications

• 5-8 years of experience in related field along with Graduate Degree is required.
• International Work experience or previous experience with working in a global setting. Qualifications. (from recognised platform will be an add on).
• Experience in handling health authorities/government bodies/local market authorities is must.
• Experience in handling life cycle management of product is required.
• Experience in handling Clinical regulatory submissions is required.
• Global exposure in terms of handling different markets.
• Excellent communication and presentation skills.
• Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.

About the department Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of highly engaged regulatory professionals. We are contributing with core RA competencies enabling NN to secure fast, high quality product approvals and life cycle management of our products. The team delivers strategic as well as operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We collaborate very closely with our colleagues in RAHQ, Denmark (DK) as well as all our colleagues in the affiliates all over the world. That makes Regulatory Affairs truly interesting and challenging place to work.
Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We\xe2\x80\x99re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things \xe2\x80\x93 from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we\xe2\x80\x99re all here - to ensure that people can lead a life independent of chronic disease.
Contact To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions). Apply now!
Deadline 10th September 2023 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\xe2\x80\x99re life changing.