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Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist

Parexel · Montpelier, VT · Regulatory Affairs

Employment type

Full-time

Work setting

On-site

Location

Montpelier, VT

Schedule

Day shift

Posted

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Job overview

The Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist is an onsite role based in Montpelier, VT. Compensation is not specified for this position, which supports Parexel's global regulatory labeling initiatives and governance committees. This role exists to provide strategic leadership and operational oversight for complex global labeling projects. It contributes to the company's goals by ensuring compliant, high-quality documentation that supports the safe and effective use of products across international markets throughout the product lifecycle.

What you'll do

  • Define and drive global labeling strategy
  • lead creation and management of core labeling documents
  • chair Labeling Review Committee
  • oversee operational labeling activities
  • ensure FDA Section 508 compliance
  • support regional implementation of updates
  • review advertising and promotional content.

What we're looking for

Skills & competencies
full-time
day shift
montpelier vt
regulatory affairs
labeling strategist
senior consultant
life sciences
global strategy
compliance
veeva rims
no weekends
no on-call
Work arrangement
  • Weekend coverage required

Why this role

Requires 5-7 years in biotech/pharma with 2+ years in global labeling/regulatory leadership; proficiency in RIMS/eDMS systems.

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
11-9199.01
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