Timothy Lay

Background

About Timothy Lay

I bring over 20 years of experience in the pharmaceutical industry, spanning Quality Control, Production, Quality Assurance, and most recently, Regulatory Affairs. My current focus is on authoring and managing high-quality Module 3 CTD dossiers for drug substances, supporting global submissions including ASMF and CEP (Europe) and CADIFA (Brazil). I have hands-on experience compiling regulatory risk assessments aligned with ICH M7, Nitrosamines, and ICH Q3D, and work closely on analytical controls and impurity profiling. As former Head of QA for an API manufacturer, I’ve worked within and refined existing quality assurance systems, managing complex regulatory expectations while guiding teams through the challenges of transitioning from paper-based processes to embedded practices. I’ve both led GMP audits (including ICH Q7) and supported numerous external inspections — giving me a practical, well-rounded understanding of compliance under pressure. With this broad operational and regulatory background, I approach challenges with cross-functional insight, clarity, and a commitment to delivering pragmatic, regulation-aligned outcomes.