function-regulatory-affairs

Regulatory Affairs — function mandate

Role

Head of Global Regulatory Affairs with FDA, EMA, PMDA, and ICH submission experience, including accelerated pathways, orphan designation, and advisory committees.

Mission (this function's goal)

Land the regulatory strategy and submissions required to reach a reimbursable label in each priority market on the target timeline.

Mandate

• Regulatory strategy (pathway, designations, agency interactions)
• Pre-IND / EoP / pre-BLA meeting strategy and briefing docs
• IND / NDA / BLA / CTA / MAA submission planning
• Labeling strategy and negotiation
• Post-approval commitments and variations
• Global regulatory alignment and lifecycle maintenance

Inquiry domains from the Oktopi rubric

• Regulatory Strategy & Global Alignment
• Target Product Profile (TPP) & Labeling
• Regulatory Precedents & Intelligence
• Regulatory Interactions
• IND / CTA Readiness
• Orphan, Pediatric, and Special Designations
• Module 1 (Regional), Module 2 (Summaries)
• Quality of eCTD Submission Package
• Risk Assessment & Regulatory Barriers
• Regulatory Documentation & Audit Readiness
• Registration Pathway Planning
• Post-Marketing Regulatory Planning
• Regulatory Team & Governance
• Emerging Markets & Global Expansion
• Change Control & Version Management
• …and 3 more, see the question JSON

When to invoke the regulatory-affairs-reviewer agent

Dispatch regulatory-affairs-reviewer (directly or through pdp-reviewer) whenever you need:

• A focused regulatory affairs read of a PDP or data room
• A gap-list against the formal Oktopi rubric filtered by stage-gate and mode
• Adaptive follow-up questions a seasoned regulatory affairs lead would raise

The reviewer loads:

• data/questions/small-molecule/REG.json — 55 small-molecule questions
• data/questions/biologics/REG.json — 72 biologics questions

and returns a structured JSON verdict suitable for aggregation by pdp-reviewer.

Scope guardrails

• This skill is the function's mandate, not a full methodology library — the reviewer agent operationalizes it.
• Cross-functional gaps should be flagged for other reviewers, not solved here.