Regulatory Affairs Leadership

Agyra Ltd offers interim and fractional senior leadership in Regulatory Affairs, acting as or supplementing your in-house team.

Working cross-functionally with development teams, I support the planning and execution of global development programs and can provide oversight and management of existing or future regulatory vendors. This gives early-stage companies direct access to senior regulatory leadership without the overhead of a full-time hire.

I also provide expert review of existing regulatory strategies and can support due diligence exercises.

Illustration of a man and woman discussing strategies in front of a target with an arrow hitting the center, representing goal-setting or achievement.

Regulatory guidance is rarely deterministic. The pathway to approval is shaped by how you engage with agencies, the evidence you generate, and the goals and objectives you're pursuing.

My starting point is always your science, goals and objectives and ultimately what success looks like for patients. I seek to understand whether you're building a program to partner, out-license, or to build a company around. From there, I work with your team to co-create a regulatory approach that serves those objectives, rather than one that forces you to fit an existing framework.

Past examples include designing a novel 'one-trial' approach negotiated with FDA to support both accelerated and full approval; securing Fast Track Designation on limited early-stage clinical data; and ensuring patient-reported outcomes were captured in an EU product label with downstream HTA implications in mind.

Regulatory Affairs Strategy

An abstract illustration of a calendar or planner with gears, a light bulb, and a potted plant nearby, representing ideas, planning, and productivity.

Agyra Ltd offers bespoke mentoring for in-house Regulatory Affairs teams, focused not just on knowledge transfer, but on developing the strategic mindset that leads to better outcomes in practice.

Working closely with emerging and existing regulatory leaders, I help build the confidence, commercial awareness, and influence needed to navigate an environment where the answers are rarely written down.

I can also provide tailored in-house training across all aspects of Regulatory Affairs.

Regulatory Affairs Mentoring

Two men discussing a project in front of a collaborative whiteboard with sticky notes and charts.

About Agyra Ltd

Agyra Ltd is a single-person strategic regulatory affairs consultancy, founded in 2026 by Alex Yates. I have worked in Regulatory Affairs since 2002, and in my career I have spent time in consultancy, large pharma, and biotech.

Through Agyra Ltd, I provide global strategic regulatory leadership, leveraging my extensive experience interacting with FDA, EMA, MHRA, PMDA, Swissmedic and other agencies globally.

I have in-depth experience in oncology, but have worked in other therapeutic areas and in biosimilars. I have built and managed regulatory affairs teams, and am passionate about talent development and supporting colleagues to reach their full potential.

I am a prior Board Director of TOPRA, The Organisation for Professionals in Regulatory Affairs

A middle-aged man with glasses and a beard, wearing a white collared shirt, smiling at the camera with a neutral background.

Contact Agyra Ltd

If you’d like to know more about my services, or how I can help you achieve your goals, then please don’t hesitate to reach out.

You can also download a PDF summary of my services here:

Summary of Services

By submitting this form, you confirm that you have read and understood Agyra Ltd’s Privacy Notice and consent to the processing of your personal data for the purpose of responding to your enquiry.