Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist

Job overview

The Senior / Regulatory Affairs Consultant - Regulatory Labeling Strategist is an onsite role based in Lincoln, NE. Compensation is not specified for this position, which supports the global regulatory labeling team at Parexel. The role provides strategic leadership and operational oversight for complex global labeling initiatives. The consultant defines labeling strategy, leads governance committees, and collaborates cross-functionally to deliver compliant documentation for life-changing therapies.

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.
• Chair and manage Labeling Review Committee (LRC) and Global Labeling Committee (GLC).
• Oversee operational labeling activities, including EU/US artwork coordination.
• Partner with regional and local regulatory leads to address Health Authority inquiries.

What we're looking for

Skills & competencies

full-time

day shift

lincoln ne

parexel

regulatory affairs

labeling

onsite

consultant

biotech

compliance

Work arrangement

• Weekend coverage required

Why this role

Global strategic leadership, supports diverse markets, 5-7 years of biotech/pharma experience.

About the employer

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