Global Regulatory Labeling Associate Director

Vertex Pharmaceuticals Inc (US)

Boston (MA)

Hybrid

USD 162,000 - 242,000

Full time

3 days ago
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Benefits offered by this job

Medical, dental and vision
Generous PTO
Student loan repayment
Matching charitable donations
401(k)

Job summary

Vertex Pharmaceuticals Inc, a Boston-based global biotechnology company, seeks a Regulatory Labeling Associate Director to lead strategic labeling for one or more products across CCDS, USPI, EuSmPC, and ROW markets. The role includes governance, cross-functional leadership, and regulatory strategy for health authority interactions.

Ideal candidates have extensive experience in global labeling, a life sciences background, and a track record of coordinating labeling across multiple jurisdictions,

Qualifications

  • Bachelor's degree in life sciences with 8 years in regulatory labeling.
  • Experience leading global labeling for CCDS/USPI/EuSmPC.
  • Ability to advise on regulatory labeling strategy and health authority interactions.

Responsibilities

  • Develop and maintain global product labeling including CCDS and major markets.
  • Lead labeling governance meetings and label working groups.
  • Advise stakeholders on regulatory labeling requirements for data.
  • Oversee interactions with health authorities on labeling matters.

Skills

Labeling knowledge
Regulatory affairs
Leadership
Cross-functional collaboration
Regulatory strategy

Education

Bachelor’s degree in life sciences

Tools

Labeling systems

Job description

Vertex Pharmaceuticals Inc, a Boston-based global biotechnology company, seeks a Regulatory Labeling Associate Director to lead strategic labeling for one or more products across CCDS, USPI, EuSmPC, and ROW markets. The role includes governance, cross-functional leadership, and regulatory strategy for health authority interactions.

Ideal candidates have extensive experience in global labeling, a life sciences background, and a track record of coordinating labeling across multiple jurisdictions,

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