Regulatory Affairs Lead - Europe

If you’re the kind of person who doesn’t just navigate regulation, but shapes it, this could be your next chapter.

This is a newly created role at the heart of a growing biopharma organisation, one that’s building something meaningful in Europe. You’ll take the lead in establishing the full regulatory framework for EU and UK operations, becoming the anchor point for all MAH activities and the go-to partner for agencies, global teams and internal stakeholders.

This isn’t a role where you step into an established machine. This is a role where you will build the machine, shape the systems, the governance, the way of working. You’ll be setting the foundation for how a growing organisation shows up to regulators across Europe for years to come.

If you’re looking for an opportunity to make a lasting impact, influence strategy, work globally and bring regulatory excellence to the forefront… this might be exactly the challenge you’ve been waiting for.

ABOUT THE ROLE:

• Laying the foundations. You’ll build out the regulatory function from the ground up, designing processes, shaping systems, and leading the transition from vendor-led to in-house capability over time.
• Owning the European regulatory agenda. You’ll define and execute strategies for EU (CP/DCP) and UK (IRP) submissions, oversee lifecycle management, and coordinate all interactions with EMA, MHRA and national authorities.
• Becoming the regulatory voice across the business. You’ll advise on compliance, interpret evolving frameworks, ensure MAH obligations are met, and act as the key regulatory partner to Quality, Supply Chain, Commercial and global affiliates.
• Driving high standards through partnership. You’ll manage external service providers, set expectations, monitor performance, and make sure everything stands up to audit and inspection scrutiny.
• Looking ahead. From risk assessments to roadmap development, you’ll contribute to the long-term regulatory blueprint, ensuring European strategy aligns with global ambitions.

ABOUT THE PERSON:

This is the perfect role for someone who is ready to own, shape and elevate a regulatory function, not just manage an existing one.

You’ll likely bring:

• Over 10 years’ experience in EU/UK regulatory affairs.
• Strong grounding in generics, biologics, and combination products.
• Deep understanding of MAH responsibilities, labelling, post-approval change management, and agency engagement.
• Experience managing vendors and leading interactions with EMA/MHRA.
• The communication skills to influence, the analytical rigour to guide decisions, and the adaptability to thrive in a fast-evolving environment.