Job Description

Regulatory Affairs Lead
Medical & Regulatory
Gatwick, UK

Join our UK Regulatory team and play a central role in delivering strategically important, timely and high‑quality submissions that help bring innovative medicines and devices to patients.

Your new role
As Regulatory Affairs Lead you will manage, plan and execute regulatory projects within the UK Regulatory, Safety & Medical Information (RSM) team. You will provide technical and strategic support to the Associate Director of RSM and to UK Regulatory Affairs (UKRA), partner with business units to align regulatory files with business needs and lead complex submissions and lifecycle changes (including new products, line extensions and strategic projects) for the MHRA and other relevant authorities.

Day‑to‑day your tasks will include

• Lead regulatory projects end‑to‑end: planning resources and budgets, providing strategic input, performing risk analysis and delivering implementation plans.
• Act as UK point‑of‑contact for allocated projects, including official meetings with health authorities (e.g., Scientific Advice), and represent UKRA in Global Regulatory Portfolio Teams where required.
• Compile, prepare and ensure submission and approval of national MAAs and other regulatory applications in collaboration with HQ, publishing, labelling, devices and cross‑functional stakeholders.
• Maintain regulatory intelligence: monitor changes in UK (MHRA) and EU legislation, evaluate relevance and interpret impact for UK operations and regulatory strategy.
• Provide accurate internal regulatory advice and training to business units on regulatory strategy, labelling requirements and compliance matters.
• Support regulatory audit and inspection readiness, paediatric obligations (PIP activities), recall procedures and other GxP‑related activities as required.

Your new department
You will join the UK Regulatory, Safety & Medical Information (RSM) team in Medical & Regulatory. The team works closely with Headquarters, UK affiliates, cross‑functional partners (Commercial, Medical, Safety, Quality, Publishing, Devices) and external stakeholders to ensure compliance and enable patient access to safe, effective products.

Your skills & qualifications
To succeed in this role, you should:

• Be a science graduate (or equivalent) with relevant pharmaceutical industry experience in a regulatory environment.
• Demonstrate extensive knowledge of regulatory legislation and processes (UK and EU) and the ability to interpret new legislation and assess business impact.
• Have proven experience managing regulatory projects and compiling regulatory submissions for medicinal products and medical devices.
• Be a strong stakeholder manager with influencing skills; able to provide clear regulatory advice and work collaboratively across HQ, affiliates and business units.
• Be proficient with Microsoft systems, comfortable prioritising tasks to meet deadlines, and able to work both autonomously and as part of a team.
• Be fluent in written and spoken English with excellent communication and presentation skills and the ability to make sound decisions on complex regulatory issues.

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. We combine scientific curiosity, warmth and determination to create lasting improvements in patient health. At Novo Nordisk you will join a collaborative team that values development, integrity and cross‑functional teamwork and offers opportunities to make a direct impact on patients.

Deadline 28th of February (Applications are reviewed on an ongoing basis)

Novo Nordisk is not your typical healthcare company. In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long‑term health. Our unordinary mindset is at the heart of everything we do. We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives. Because it takes an unordinary approach to drive real, lasting change in health.

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.