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- Tasks: Lead regulatory projects and manage submissions for innovative medicines and devices.
- Company: Join Novo Nordisk, a leader in healthcare innovation and patient impact.
- Benefits: Collaborative culture, career development, and the chance to make a real difference.
- Why this job: Be at the forefront of healthcare, shaping regulations that improve patient lives.
- Qualifications: Science graduate with regulatory experience and strong stakeholder management skills.
- Other info: Inclusive environment focused on long-term health solutions and impactful change.
The predicted salary is between 36000 - 60000 £ per year.
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.
Regulatory Affairs Lead employer: Novo Nordisk
Contact Detail:
Novo Nordisk Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Lead
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its regulatory processes. Understand their recent submissions and challenges. This will help you tailor your answers and show that you're genuinely interested in their work.
✨Tip Number 3
Practice your pitch! Be ready to explain how your skills align with the role of Regulatory Affairs Lead. Highlight your project management experience and your ability to navigate complex regulatory landscapes.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining our team at Novo Nordisk.
We think you need these skills to ace Regulatory Affairs Lead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Affairs Lead role. Highlight your relevant experience in regulatory projects and your understanding of UK and EU legislation. We want to see how your skills align with our mission!
Showcase Your Stakeholder Management Skills: In your application, emphasise your ability to manage stakeholders effectively. Share examples of how you've influenced decisions or collaborated across teams. This is key for us as we work closely with various departments and external partners.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language to explain your experience and achievements. We appreciate clarity, especially when it comes to complex regulatory issues!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Novo Nordisk
✨Know Your Regulatory Stuff
Make sure you brush up on UK and EU regulatory legislation before the interview. Being able to discuss recent changes and their potential impact on the business will show that you're not just knowledgeable but also proactive in your field.
✨Showcase Your Project Management Skills
Prepare examples of past regulatory projects you've managed. Highlight how you planned resources, executed strategies, and navigated challenges. This will demonstrate your ability to lead complex submissions and lifecycle changes effectively.
✨Be Ready for Stakeholder Scenarios
Think about times when you've had to influence stakeholders or collaborate across teams. Be ready to share these experiences, as strong stakeholder management is key for this role. Show them you can communicate clearly and work well with others.
✨Practice Your Communication Skills
Since excellent communication is crucial, practice articulating complex regulatory concepts in simple terms. You might be asked to explain a regulatory issue during the interview, so being clear and concise will set you apart from other candidates.