Chemistry, Manufacturing and Controls (CMC) Regulatory Specialist

CMC Regulatory Specialist Company: Novo Nordisk Global Business Services (GBS) Shape regulatory strategies that bring life-changing medicines from development through approval – and into the hands of patients across the globe. Your new role As a CMC Regulatory Specialist, you will take ownership of complex regulatory processes that directly enable Novo Nordisk's medicines to reach patients worldwide. Operating at the intersection of science, strategy and global compliance, you will navigate diverse regulatory landscapes and drive submissions across major markets. Your work will span the full product lifecycle – from early development through post-approval – requiring both deep technical expertise and strategic agility. Your responsibilities will span the following key areas: Regulatory submissions to health authorities worldwide Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies across global markets Prepare, maintain and submit regulatory files including MAA/NDA/BLA, NBOp, CE, CTA/IND, device files, site master files, renewals, post-approval changes and commitments Respond to questions from health authorities and manage ongoing interactions with affiliates to ensure alignment and compliance Regulatory interactions with health authorities Plan and conduct regulatory interactions with health authorities, including preparation of meeting requests, meeting packages, rehearsals and formal meeting minutes Provide strategic input to affiliates in preparation for health authority interactions Represent Novo Nordisk externally, actively communicating within your field of expertise RA matrix team membership and cross-functional collaboration Represent the Regulatory Affairs function in RA matrix teams, ensuring alignment of planning and strategy across areas Ensure effective information flow to the matrix team and broader stakeholders Serve as RA representative in International Study Groups, stakeholder working groups, core groups and expert groups Innovation, compliance and continuous improvement Drive innovation and optimisation projects within the regulatory space Evaluate guidelines, requirements and their impact on projects Conduct impact assessments of change requests and deviations Act as Product Responsible for Regulatory Compliance Act as substitute for more senior regulatory roles when needed 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. Within R&D, you will join a regulatory team focused on Chemistry, Manufacturing and Controls (CMC), where you will work alongside experienced regulatory professionals dedicated to navigating the global regulatory landscape. The team operates with a high degree of cross-functional collaboration – interfacing with development, manufacturing, quality and commercial stakeholders – to ensure our products meet the highest regulatory standards across all major markets. Your skills & qualifications We are looking for a seasoned regulatory professional who thrives in complexity, brings strategic thinking to every interaction and is energised by navigating global regulatory environments. You will bring: A Master's degree with typically more than 12 years of relevant experience, or a PhD with typically more than 5 years of relevant experience across several regulatory disciplines. A Bachelor's degree with a minimum of 10 years of relevant experience across several qualifiers may also be considered Solid knowledge of regulatory science and requirements across major markets (EU, US, China, Japan), with experience spanning areas such as early- and late-stage drug development, life cycle management, health authority interactions and CMC development Strong strategic mindset with proven ability to translate regulatory strategies into ambitious goals, handle ambiguity and make bold, well-informed decisions in complex stakeholder landscapes Excellent planning, coordination and stakeholder management skills, with the ability to structure complex tasks, eliminate unnecessary complexity and drive alignment across functions and cultures Fluency in written and spoken English, combined with proven negotiation skills and the ability to represent Novo Nordisk at an international level of expertise 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. Deadline 7 August 2026. Applications are reviewed on an ongoing basis. 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. Experience Level Mid Level