Regulatory Affairs Specialist - RA Manufacturing Facilities & Projects

Are you excited to be part of a dynamic, ever-evolving environment while contributing to Novo Nordisk’s purpose of driving change to defeat serious chronic diseases? Are you passionate about leading cross-product and cross-site projects, and motivated to support the launch of both new and established products across our current and future manufacturing facilities worldwide? Do you aspire to take ownership of manufacturing facilities–related projects within the Diabetes, Obesity, and Rare Disease portfolios? If so, this opportunity could be the perfect fit for you. 

Apply now and join us in building a life-changing career. 

Your new role 

As a Regulatory Affairs Specialist, you will join the RA Facility & Projects team, contributing to our core mission of securing efficient submissions and predictable approvals worldwide through strong strategic partnerships with key stakeholders. In this role, you will lead manufacturing facility approvals for both new and established products, while driving a broad range of life cycle management (LCM) activities, demonstrating a proactive approach to enhance manufacturing capacity, flexibility, and continued compliance. 

Key responsibilities of this role include:  

• Be accountable for and lead end-to-end regulatory submission activities for cross-product, cross-site, and manufacturing facility/equipment change projects by defining innovative regulatory strategies and driving their execution in collaboration with stakeholders across Lines of Business (LoB), securing timely approvals. 

• Contribute to new product submissions by leading regulatory strategies and activities related to manufacturing facilities and equipment, in close collaboration with stakeholders across drug substance and drug product sites. 

• Coordinate activities related to the creation and maintenance of dossier documentation for manufacturing facilities, manufacturing equipment, and associated processes (such as cleaning validation, sterilisation, environmental monitoring, media-fill etc). 

• Demonstrate strong leadership by setting the strategic regulatory direction for projects, facilitating regulatory submission activities, and in providing quality responses to health authority questions in close collaboration with Global Manufacturing & Supply (GMS), Quality Assurance (QA), external partners, and affiliates.  

• Acting as an RA Site Partner by fostering close collaboration with manufacturing sites to proactively align on planned site-level changes, provide regulatory guidance, and support during audits and inspections.  

• Supporting on activities related to Change Requests, deviations, regulatory assessments for variations and investment projects, as well as the creation and management of regulatory events, content plans, and other related tasks within regulatory systems such as Vault Quality and Vault RIM, in accordance with global processes.  

The role involves a high degree of planning, coordination, and execution of projects and tasks. You are expected to continuously adapt to evolving priorities and changes in work processes. Success in this role requires the ability to collaborate effectively with colleagues across functions, organisational levels, and geographies, supported by strong cultural awareness and the ability to engage, influence, and build strong relationships with stakeholders. 

Your new department 

RA Facility & Projects is part of the RA CMC LCM area within RA CMC & Device — a global organisation of more than 200 dedicated professionals working across multiple regions. The department plays a vital role in making medicines available to patients worldwide by ensuring efficient, high-quality regulatory submissions and approvals.  

RA Facility & Projects is comprised of passionate and highly skilled professionals with extensive regulatory expertise, complemented by strong project management and coordination capabilities. We, the team of eight people work closely with departments across RA CMC & Device and line of business to drive collaboration and deliver value. Guided by the Novo Nordisk Way, we strive to lead by example, support one another, and foster a collaborative, inclusive, and engaging work environment where people can thrive. 

The position is based in Søborg, Denmark, and offers exposure to global projects as well as close collaboration with colleagues across cultures and time zones. 

Your skills and qualifications 

You bring a strong scientific and technical foundation, built through your education and extensive experience within pharmaceutical operations, including manufacturing, CMC process development, quality assurance, and regulatory affairs. 

To succeed in this role, you are expected to have: 

• A university degree in Pharmaceutical Engineering, Life Sciences, or a related field.  

• At least 8 years of relevant experience within regulatory affairs, manufacturing, and quality in the pharmaceutical industry.  

• Proven experience with regulatory submissions and approvals, including interactions with health authorities.  

• Demonstrated track record of driving regulatory strategies for the approval of new or revamped manufacturing facilities, supported by strong GMP knowledge and expertise. 

• Hands-on experience working in environments characterised by tight timelines, high complexity, and diverse, non-standard tasks.  

• Strong project management skills, with the ability to navigate complex stakeholder landscapes effectively.  

• A collaborative mindset and a genuine interest in working with colleagues from diverse cultural and professional backgrounds. 

On a personal level, you are recognised for your proactive and positive mindset, combined with a strong can-do attitude. You possess excellent communication and collaboration skills, enabling you to build strong relationships and work effectively with a diverse range of stakeholders. You are self-motivated and demonstrate a high level of initiative, allowing you to succeed both independently and as part of a collaborative team.