Global Regulatory Labeling Director — Remote

Vertex Pharmaceuticals LLC

Boston (MA)

Hybrid

USD 162,000 - 242,000

Full time

3 days ago
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Benefits offered by this job

Annual bonus
Equity awards

Job summary

Vertex Pharmaceuticals LLC seeks a Regulatory Labeling Associate Director to lead labeling strategy and global labeling for one or more products, including CCDS, USPI, and ROW materials. You will guide governance, coordinate with health authorities, and oversee cross-functional labeling activities from Boston or remote.

The role emphasizes strategic thinking, stakeholder advisory, and regulatory risk management.

Qualifications

  • Bachelor’s degree, preferably in life sciences.
  • Typically requires extensive experience in regulatory affairs focused on global labeling.
  • Experience leading labeling governance and cross-functional teams.

Responsibilities

  • Develops and maintains global product labeling (CCDS, USPI, ROW labels).
  • Leads labeling governance meetings and advises stakeholders on regulatory labeling requirements.
  • Oversees lifecycle management of labeling and interactions with health authorities.

Skills

Global labeling
CCDS knowledge
FDA/EMA awareness
Regulatory strategy
Leadership
AI-driven tools awareness

Education

Bachelor’s degree in life sciences

Job description

Vertex Pharmaceuticals LLC seeks a Regulatory Labeling Associate Director to lead labeling strategy and global labeling for one or more products, including CCDS, USPI, and ROW materials. You will guide governance, coordinate with health authorities, and oversee cross-functional labeling activities from Boston or remote.

The role emphasizes strategic thinking, stakeholder advisory, and regulatory risk management.

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