Regulatory Affairs Manager UKIE

Field of work: Regulatory & Medical

Posting Date: 11 Nov 2025

Application deadline:
26/11/2025

Location:
Maidenhead SL6 3UD, Berkshire, United Kingdom

Contract type:
Permanent

Job ID:
3940

Shape the LEO Pharma of tomorrow
LEO Pharma is looking for an experienced Regulatory Affairs professional to join our UK & Ireland team in a pivotal role ensuring our dermatology and rare disease portfolio reaches patients safely and in compliance with all regulatory requirements. If you're ready to take the next step in your career and make an impact, this is the opportunity for you

At LEO Pharma, we are global leaders in medical dermatology. We have 117 years' experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicines.

In the Regulatory Affairs team, we share a "challenge accepted" mindset and are guided by our winning behaviours of simplification, collaboration, and accountability, to achieve our goals. The ideal candidate will be able to work collaboratively as part of both a local and global team.

Your Role
As Regulatory Affairs Manager UKIE at LEO Pharma, you will work across the full product lifecycle, from clinical development to marketing authorisations - influencing strategy and delivering submissions that make a genuine difference.

In this role, you will be the local regulatory point of contact for both the UK (MHRA) and Ireland (HPRA), managing a diverse portfolio, including our pipeline and innovative products across dermatology and rare disease. You'll provide strategic local input into global drug development, lead complex regulatory submissions, and maintain excellent relationships with authorities and trade associations.

Key Responsibilities

• Securing and maintaining clinical trial and marketing authorisations for LEO Pharma products in the UK & Ireland.
• Providing strategic regulatory input from the local market to global development projects.
• Managing high‑complexity submissions under tight timelines.
• Maintaining regulatory databases and ensuring documentation accuracy.
• Representing Regulatory Affairs in global and external meetings.
• Establishing and developing effective relationships with MHRA, HPRA, EMA, and industry associations.

This role is based at our Head Office in Maidenhead, with the option for hybrid working.

Your Qualifications

• Professional fluency in English.
• Degree in pharmacy, life sciences, or equivalent by experience.
• Significant Regulatory Affairs experience within the pharmaceutical industry, ideally across both clinical and marketing authorisations.
• Dermatology and/or rare disease experience would be advantegous.
• Experience of providing strategic local regulatory input to global drug development.
• Proficiency with regulatory systems/workflows and document approval tools.
• Excellent project management skills and ability to work effectively within a dynamic environment.
• Comprehensive knowledge of UK/Ireland regulatory frameworks and procedures.
• Experience in maintaining regulatory databases.
• Prior experience of partnering with local and global teams, and industry stakeholders.

LEO Pharma is built on collaboration, innovation and curiosity. Is this you?

Your Application
You do not need to upload a cover letter, but feel free to add a few sentences in your CV on why this position has your interest.

Beyond the skin
Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

Join us on our journey Beyond the Skin. Apply today

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