For over 100 years we have been driving change to defeat diabetes, but we know that what got us here today is not necessarily what will make us successful in the future. We are now transforming our business and taking our expertise into new territories including obesity and rare blood and endocrine diseases.
Our story is one of incredible growth and success, which has culminated in receiving many prestigious awards, such as Best Places to Work and Vitality : Britain's Healthiest Workplace.
The position
Would you like to play a key role in the development and delivery of new therapies to patients? Do you have experience working with biologics and supporting the introduction of new treatments to the market? If so, we are recruiting for an opportunity that aligns with your expertise.
As a Regulatory Affairs Lead at Novo Nordisk, you will:
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Manage, plan, and execute regulatory initiatives within the UK Regulatory, Safety, and Medical Information (RSM) team.
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Offer technical and strategic support to the Director of RSM and the UK Regulatory Affairs team.
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Prepare and deliver timely and competitive submissions to the MHRA, aligning with national and EMA regulatory requirements.
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Collaborate across UK business and with Global and Regional teams to align regulatory strategies with business needs
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Provide regulatory expertise to team members by ensuring prioritisation and efficiencies for Life Cycle management of all UK products
You will also drive pipeline management, innovative initiatives, GxP activities, and strategic regulatory projects to support and elevate organizational success.
This is a hybrid role, requiring two days per week in our office in Gatwick
Qualifications
To be successful in this role we imagine that you possess:
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A science degree (or equivalent) with a proven track record in regulatory projects, extensive knowledge of UK and EU regulatory legislation, and solid pharmaceutical industry experience
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Experience in biologics and prescription medicines, including successfully bringing innovative therapies to market, is essential.
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Strong communication, presentation, decision:making, and stakeholder management abilities, along with the capacity to prioritize tasks and lead complex projects
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Organizational skills, while being proactive, and adaptable, with the ability to work effectively both independently and collaboratively within a team.
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Experience in team leadership or demonstrated strong leadership skills is an advantage.
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Fluent in written and spoken English with a solid understanding of regulatory intelligence interpretation.
About the department
In this role, you will report to the Director of Regulatory, Safety, and Medical Information and collaborate colsely with the UK Regulatory team, consisting of seven dedicated memebers who work seamlessly together.
Our team is proud to have achieved exceptional Employee survey results, including a perfect 100 score in areas such as teamwork, valuing diverse perspectives, and mutual respect from their manager. Additionally, we scored 100 in the Purpose category, reflecting our shared commitment to meaningful and impactful work.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That's why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it's a collective effort. Together, we go further. Together, we're life changing.
What We Offer
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Bonus: We do our best work to succeed together. When goals are reached, you'll be rewarded through our bonus scheme
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Your workplace: Our offices will