P2
QUALIT.REGULATOA5B4.P2
Regulatory Affairs — P2

JobFrame · QUALIT.REGULATOA5B4.P2

Quality Assurance & Compliance · Regulatory Affairs

P2 · P2 — Developing Professional

Median pay · United States

$72,357

$56,843$92,106 · USD · annual · national base (function pricing in review)

Median pay

$72,357

$56,843–$92,106

Level

P2

Super-function

operations

Demand-heat

moderate

4.5% growth

Summary

Regulatory Affairs focuses on securing and maintaining marketing authorization for drug and biologic products by preparing and submitting eCTD/CTD dossiers to health authorities (FDA, EMA, and 60+ ICH agencies), developing regulatory strategies for new products, and managing agency relationships and correspondence. Distinct from sibling Quality Assurance focuses (e.g., GMP quality systems, validation, or audit) in that it centers on the regulatory submission lifecycle — application types (IND/NDA/ANDA/BLA/510(k)), labeling/CMC content, regulatory intelligence on changing requirements, and direct interaction with regulatory agencies — rather than internal manufacturing/quality system compliance.

This level — P2 P2 — Developing Professional

Early-career professional; developing skills, handles routine tasks with some independence

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