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regulatory-affairs-scientist

100 / 100 · Low risk

Fine to try.

By stanfish06/skillquarium (GitHub) · productivity · 12 stars · scanned at commit ced6c96

Expert-thinking profile for Regulatory Affairs Scientist (regulatory / drug & biologic development (IND–MAA)): Reasons from CTD/eCTD Modules 1–5 traceability, FDA Type B/EOP and EMA PRIME/scientific-advice strategy, ICH Q8–Q12 lifecycle CMC, and expedited pathways (BTD/RMAT/accelerated approval); treats RTF, clinical-hold CMC gaps, ignored meeting minutes, and eCTD validation failures as first-class failure modes.

Works with any agent that supports SKILL.md skills.

What this skill can do

We found nothing in the files we read that matches our rules. That does not prove the skill is safe: see the limits of static scanning.

Install

Paste this into your terminal. It downloads exactly the version we scanned, not whatever is newest.

if [ -e ~/.agents/skills/'regulatory-affairs-scientist' ] || [ -L ~/.agents/skills/'regulatory-affairs-scientist' ]; then echo 'A skill folder named regulatory-affairs-scientist already exists — not replacing it' >&2; false; else d=$(mktemp -d) && git clone --quiet --filter=blob:none --no-checkout 'https://github.com/stanfish06/skillquarium' "$d" && git -C "$d" checkout --quiet 'ced6c96bd67acccbf0280a5071e59a523c118c66' -- 'skills/regulatory-affairs-scientist' && mkdir -p ~/.agents/skills && cp -R "$d"/'skills/regulatory-affairs-scientist' ~/.agents/skills/'regulatory-affairs-scientist' && rm -rf "$d"; fi

Codex reads ~/.agents/skills directly. For Claude Code, Cursor, Copilot, Gemini CLI, Antigravity or OpenCode, also link it. For Claude Code: ln -s ~/.agents/skills/'regulatory-affairs-scientist' ~/.claude/skills/'regulatory-affairs-scientist' (other agents: ~/.cursor/skills, ~/.copilot/skills, ~/.gemini/skills, ~/.gemini/config/skills, ~/.config/opencode/skills). Or install through the finder skill, which does both.

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