Regulatory Affairs Specialist Shape the regulatory path for one of Novo Nordisk's most important obesity and cardiometabolic assets – and help bring transformative treatments to patients worldwide. Your new role As a Regulatory Affairs Specialist, you will join our Regulatory, Quality and Clinical Reporting organisation supporting one of our late-stage development projects within the obesity and cardiometabolic health therapy area. You will lead submission-related regulatory activities in close collaboration with the Global Regulatory Lead (GRL), playing a central role in planning and overseeing global marketing authorisation submissions in a dynamic and evolving development environment. Your key responsibilities will include: - Contributing to the late-stage development strategy for one of Novo Nordisk's key assets within the obesity and cardiometabolic health therapy area - Developing and planning the global marketing authorisation submission strategy for a highly complex development programme pursuing multiple indications - Driving innovative and fit-for-purpose submission strategies, including exploring new ways of structuring and executing submissions to support complexity, speed, and quality - Leading and guiding the regulatory submission team and cross-functional stakeholders to ensure aligned execution, strong decision-making, and timely delivery of submission activities - Working across development projects in combination with life cycle management activities, ensuring a coherent and forward-looking regulatory strategy You will report to the head of the department and take an active part in department-related activities, including improvement projects across Regulatory Affairs. 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. Our department is responsible for developing and executing the regulatory strategy for one of our late-stage development programmes. We work as an integrated part of the global development and research projects and play a key role in cross-functional teams – providing regulatory expertise and tactics to the product development plan. The position is based in Søborg, Denmark. Your skills & qualifications We are looking for a Regulatory Affairs Specialist who brings deep expertise in regulatory strategy and can navigate the intersection of development projects and life cycle management. You'll bring with you: - A Master's or Ph.D. degree in Life Science, Pharmaceutical or Health Science - Minimum 7–8 years of experience in Regulatory Affairs with solid, hands-on experience in global marketing authorisation applications - Proven experience working with regulatory strategy across development projects and life cycle management - Strong negotiation skills and a sound understanding of the pharmaceutical value chain - Excellent communication skills with the ability to cooperate at any organisational level - Fluency in written and spoken English On a personal level, you thrive in collaborative team settings and demonstrate strong leadership. You exhibit excellent organisational and project management skills with robust problem-solving abilities, and you maintain a strategic focus. A positive, can-do attitude is essential, along with the capacity to remain calm and composed in high-pressure situations. 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 At Novo Nordisk, you'll join a global healthcare company with a unique culture and strong results. We offer continuous learning, career development, and benefits tailored to your life and career stage. Salary: For this role, the Annual Base Salary ranges from 742,600.00 to 1,091,600.00 DKK, corresponding to the level of the position. The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience. Incentives and Benefits: The salary package may include short-term and/or long-term incentives as well as other employee benefits based on position level, location, functional area and relevant market benchmarks. Learn more about our Reward Philosophy <a title="https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html" href="https://www.novonordisk.com/careers/working-at-novo-nordisk/total-rewards-benefits.html">here</a> Deadline Please submit your application by 30 July 2026. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. All applications must be submitted via the official application channel. 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.

Regulatory Affairs Specialist (Søborg, Capital Region of Denmark, DK) @ novonord

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