Why work with me
I am a regulatory and quality compliance professional with over 15 years of industry experience. My consultant and contractor work supports global regulatory strategy, cross-functional collaboration, and compliance with regulatory agency requirements. I provide freelance regulatory consulting and contracting with a focus on CMC, global compliance, and quality systems. I am actively involved in professional networks including The Organisation for Professionals in Regulatory Affairs (TOPRA), the European Medical Writers Association (EMWA), and the Research Quality Association (RQA).
For the last eight years, I have focused primarily on providing remote regulatory compliance support from my home office through my limited company. For eight years leading up to 2018, I held Quality Assurance (QA) site jobs. My QA experience is essential to CMC writing, CTD Module 3, and parts of CTD Module 2, as QA departments ensure all company activities align with regulatory standards and support the development of safe, effective, and high-quality products. Early in my compliance career, I was a clinical trial auditor at a CRO, so I have a solid grounding in the requirements for clinical trial documentation.
What I do best
I specialise in regulatory CMC, intelligence, and quality systems across all phases of the product lifecycle. I simplify complex regulated requirements. I combine writing and compliance mindsets.
• I contribute to regulatory submissions for mature companies and those who are new to industry.
• I write and review scientific and regulated documents to ensure consistency, clarity, and adherence to global standards.
Who I help
I support regulatory and operations teams who need expert documentation, auditing insight, or submission-readiness support. I also help smaller biotech and medtech firms build and strengthen their regulatory foundations from early-stage to market entry.
What I want next
I want a mid-to-senior level regulatory role where I can apply my broad cross-functional expertise. I want to contribute to smarter submissions, stronger compliance, and smoother regulator engagement. I am especially interested in organisations that value ethical science, innovation, and clear communication.
What I do
I write and review documentation to meet global compliance standards.
How I do it expertly
• I have extensive experience with GxP systems, CMC, clinical, and post-marketing documentation.
• I have deep knowledge of worldwide regulatory requirements.
• I have a proven track record in managing audits, SOPs, CAPAs, and regulatory agency inspection readiness.
• I have strong project management and communication skills.
Problems I solve
• Gaps in submission or documentation quality.
• Time-pressured deliverables without the internal writing bandwidth.
• Communication disconnects between science, quality management, and regulatory affairs.
Organisations that should invest in speaking with me
• Pharma, biotech, and CROs needing regulatory writers across Europe and global markets.
• Medtech and diagnostics firms navigating regulatory filings.
• Scale-ups facing new compliance frameworks or increased agency scrutiny.
• Teams that need calm, precise, cross-functional support under pressure.
Contact me if you are seeking expert guidance and comprehensive solutions in the dynamic field of biotechnology.
Sectors I work in
Biotechnology
Biotechnology concerns the application of science, technology, and platforms to living organisms, parts, products, and models. It can be used to alter living or non-living materials to produce knowledge, goods, and services. I use my biotechnology understanding to work in other areas like life science, therapeutics and diagnostics, and the environment.
Life science
Life science is the study of living organisms and life processes. It concerns biotechnology, therapeutics, and diagnostics, and the environment. It considers everything from the food we eat to the medical cures we seek to the plants and animals in our environment. Thirty-plus years of life science experience allows me to work in life science-related sectors.
Therapeutics and diagnostics
The pharmaceuticals industry produces medicinal drugs.
The medical devices industry develops products or equipment intended for a medical purpose.
Combination products combine drugs, devices, and biological products. Or drugs and devices. Or biological products and devices. Or whatever other combination you thought up.
All industries concern product manufacture, distribution, preparation, use, and sale.
Environment
The environment is all the living and non-living elements and their effects that influence life. The environment includes the built environment. The environment is the air, water, and land where humans, animals, and plants live. It includes the natural world that might be affected by human or animal activity. Environmental conditions can affect people, animals, and plants, and vice versa.
Testimonials
What people say about working with me...