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).
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
Testimonials
What people say about working with me...