JobFrame · QUALIT.REGULATOA5B4.P4
Quality Assurance & Compliance · Regulatory Affairs
P4 · P4 — Senior Professional
Median pay · United States
$109,466
$85,995 – $139,343 · USD · annual · national base (function pricing in review)
Median pay
$109,466
$85,995–$139,343
Level
P4
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 — P4 P4 — Senior Professional
Seasoned professional; handles complex tasks, may lead small teams or projects
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$258 · $79/mo · $790/yr
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$490 · $149/mo · $1,490/yr
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