Senior Regulatory Publishing Lead — Global Submissions

Vertex Pharmaceuticals

Boston (MA)

On-site

USD 117,096 - 126,739

Full time

14 days+
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Job summary

Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule.

You will manage a portfolio of submissions, coordinate with regulatory document authors and submission managers, and drive process improvements ensuring compliant, high-quality output across programs.

Qualifications

  • Bachelor’s degree in life sciences or technology field is required.
  • 7 years of eCTD publishing experience is typically required.
  • Experience with regulatory publishing processes and HA submissions.

Responsibilities

  • Creates published output for submissions and assembles components per health authority guidance.
  • Validates submissions and manages interdependencies across program portfolios.
  • Collaborates with submission managers and regulatory leads to meet timelines.

Skills

eCTD publishing experience
Regulatory publishing software
Health authority guidelines
Portfolio management
Cross-functional collaboration
Attention to detail
EDMS usage

Education

Bachelor’s Degree in life sciences or technology

Job description

Vertex Pharmaceuticals in Boston is seeking a Regulatory Publishing Senior Manager to lead the creation, assembly and publishing of electronic submissions for global health authorities, delivering accurate content on schedule.

You will manage a portfolio of submissions, coordinate with regulatory document authors and submission managers, and drive process improvements ensuring compliant, high-quality output across programs.

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