Regulatory Affairs Leadership

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Agyra Ltd offers interim and fractional senior strategic and operational leadership in Regulatory Affairs, to either supplement or act as your in-house team.

I work seamlessly with cross-functional colleagues to support the development and execution of global development programmes.

I can also provide oversight and management of your existing or future Regulatory Affairs vendors.

Regulatory Affairs Strategy

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Agyra Ltd can lead or support the development of compelling and innovative global regulatory strategy to maximise the chance of success of your development programmes.

Working closely with you, I will identify opportunities to expedite development, increase efficiency and to gain valuable designations (such as US BTD).

I can also provide expert review and advice relating to existing strategies, and can support due diligence exercises.

Regulatory Affairs Mentoring

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Agyra Ltd offers bespoke industry mentoring for your in-house teams. Primarily, but not exclusively, working with your Regulatory Affairs colleagues, I take a personal and tailored approach to support professional development.

I work closely with you to understand your goals & objectives, and can support emerging and existing Regulatory Affairs leaders to maximise their potential.

I can also offer in-house training in all aspects of Regulatory Affairs.

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 current Board Director of TOPRA, The Organisation for Professionals in Regulatory Affairs

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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.

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