Senior RA Professional for Development Project within Obesity

The position

offers ample opportunities for you to continue your individual development in a dynamic, innovative, and collaborative environment, that calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people. Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site office-based work in Søborg, Denmark where our team is based. Qualifications To be a competitive candidate, you should have: A master’s degree or Ph.D. in life sciences, engineering, or another relevant academic field, combined with 5-7 years of regulatory experience within development in the pharmaceutical and/or medical device industry A good understanding of the R&D (research & development) value chain from the medical device and/or pharmaceutical industry Experience in delivering on global regulatory strategies (drug or device), including employment of expedited and accelerated pathways across the major regulatory agencies globally and handling regulatory documentation for pharmaceutical or device development An interest and understanding of management of diabetes and/or obesity would be an advantage Experience in interacting with regulatory authorities on an international scale On a personal level, you demonstrate proactivity and pragmatism whilst being flexible and change oriented, you like to experiment and see opportunities rather than limitations in challenging situations and you are a team player who assists your colleagues and works for joint objectives, shows an inclusive mindset, and respects the diversity in others. About the department RA Obesity is a new and expanding area and will soon be 30 dedicated and highly engaged Managers, Global Regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects within Obesity and Diabetes - that span across a wide array of domains and functional areas - and in are responsible for delivering and executing global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications. We are responsible for driving regulatory strategy, label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, pediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.