Regulatory Affairs Professional

Regulatory Professional II Company: Novo Nordisk Global Business Services (GBS) Shape global regulatory strategies that bring innovative therapies to patients worldwide. If you thrive on complexity, enjoy building bridges across borders and want your work to directly influence how health authorities view our pipeline – this role is for you. Your new role As a Regulatory Professional, you will drive regulatory submissions and strategy development across global health authorities, while mentoring colleagues and contributing to the continuous evolution of our regulatory practice. You will work in a dynamic environment where strategic thinking, proactive problem-solving and cross-cultural collaboration come together every day. Your key responsibilities will include: Driving regulatory submissions to health authorities worldwide: lead submission planning, apply regulatory intelligence and develop strategy; drive preparation, maintenance and submission of regulatory files (MAA/NDA/BLA, CTA/IND, Site Master File, renewals, post-approval changes and commitments) and lead interactions with affiliates Supporting health authority interactions: contribute to the planning and conduct of regulatory authority interactions, including meeting requests, meeting packages, rehearsals and minutes from formal meetings, and provide input to affiliates preparing for their own health authority engagements Representing RA in the matrix team: ensure alignment of planning and strategy across areas and secure a strong information flow between the RA function and the wider matrix team Monitoring submissions and handling renewals: drive monitoring of upcoming submissions in Vault RIM, assess national documentation requirements, conduct high-level planning and take responsibility for the overall planning and initiation of global renewals Evaluating guidelines and driving innovation: stay ahead of evolving regulatory landscapes and contribute to innovation projects that strengthen how we work Mentoring and training colleagues: share your expertise to help others grow and build collective capability within the team Your new department In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. You will join a Regulatory Affairs team that sits at the heart of our global development efforts, partnering closely with affiliates, health authorities and cross-functional colleagues to ensure that our therapies reach patients efficiently and safely. Here, your strategic mindset and regulatory expertise will have a tangible impact on the speed and success of our pipeline. Your skills & qualifications We are looking for a strategic and proactive regulatory professional who brings both technical depth and the cultural awareness needed to navigate a global stakeholder landscape. You'll bring with you: Master's degree with 7+ years' relevant working experience within Regulatory Affairs, including solid knowledge of regulatory science and requirements across EU, US, China and Japan Proven experience across the drug development lifecycle – early- and late-stage development, Life Cycle Management, label development, health authority interactions, device development and regulatory intelligence Strong understanding of the R&D value chain and broader pharma context, with appreciated additional knowledge in areas such as CMC, project management, drug-device combination products, quality, clinical pharmacology or pharmacovigilance A strategic mindset combined with boldness in decision-making, accountability, persistence and the ability to deliver results that have direct impact within and beyond your unit Strong communication, mentoring and team skills, an inclusive mindset and the ability to adjust quickly in a continuously developing environment Fluency in written and spoken English Working at Novo Nordisk Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. What we offer There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.