This handles the regulatory affairs side of product development, focusing on compliance documentation, submission preparation, and interaction with regulatory bodies. You'd reach for this when dealing with FDA submissions, CE marking, or other regulatory pathways where you need to structure complex compliance documents and track regulatory requirements. The approach here is methodical and document-heavy, which matches what regulatory work actually demands. It's built for scenarios where getting the paperwork right matters as much as the product itself, and where missing a compliance requirement can derail an entire launch timeline.
npx skills add https://github.com/alirezarezvani/claude-skills --skill regulatory-affairs-head