Senior Regulatory Labeling Strategist

Job overview

The Senior Regulatory Labeling Strategist is an onsite role based in Salem, OR, with compensation not specified. This position provides strategic leadership and operational oversight for complex global labeling initiatives across foundational and non-foundational markets. This role exists to develop, govern, and maintain regulatory labeling content that supports the safe and effective use of products globally. The strategist collaborates cross-functionally to ensure compliant, high-quality documentation throughout the product lifecycle.

What you'll do

• Define and drive global labeling strategy across foundational and non-foundational markets.
• Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile.
• Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team.
• Oversee operational labeling activities, including EU/US artwork coordination, EMA linguistic reviews, and U.S.
• SPL submissions.

What we're looking for

Skills & competencies

full-time

day shift

onsite

salem or

parexel

regulatory affairs

labeling

global strategy

compliance

governance

no on-call

no travel

Work arrangement

• Weekend coverage required

Why this role

Opportunity to shape global labeling strategy and lead governance processes for innovative products.

About the employer

Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.