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Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist

Parexel · Washington, DC · Regulatory Affairs

Employment type

Full-time

Work setting

On-site

Location

Washington, DC

Schedule

Day shift

Posted

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Job overview

The Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist is an onsite role based in Washington, DC. Compensation is not specified for this position, which supports global labeling initiatives for life-changing therapies. This role exists to provide strategic leadership and operational oversight for complex global labeling. The strategist defines labeling strategy, leads governance committees, and ensures compliant documentation throughout the product lifecycle to support safe and effective use across international markets.

What you'll do

  • Defines global labeling strategy across foundational and non-foundational markets.
  • Leads creation and management of core labeling documents like CDS, USPI, and EU SmPC.
  • Chairs Labeling Review Committees and manages governance frameworks.
  • Oversees operational labeling activities including artwork coordination and health authority negotiations.

What we're looking for

Skills & competencies
full-time
day shift
washington dc
parexel
regulatory affairs
labeling strategy
global compliance
onsite
no weekends
no on-call
Work arrangement
  • Weekend coverage required

Why this role

Global strategic leadership, governance committee management, cross-functional influence.

About the employer

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

Additional details

Industry sector
54
Industry
Administrative Management and General Management Consulting Services
Occupation code
11-9199.02
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