Hybrid Senior Director, Regulatory Transformation & Innovation

Vertex Pharmaceuticals LLC

Boston (MA)

Hybrid

USD 216,000 - 325,000

Full time

6 days ago
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Job summary

Vertex Pharmaceuticals is seeking a Senior Director of Regulatory Transformation Innovation to lead the modernization of Global Regulatory Affairs processes using digitization, AI/ML, analytics, and automation. This strategic leader will guide initiatives across GRA and partners, delivering measurable business value and a culture of innovation.

The role is hybrid, requiring three or more onsite days per week at the Boston Seaport location, with a focus on transforming regulatory content,

Qualifications

  • Bachelor’s degree in a life sciences, regulatory, or related field.
  • 10 years of experience in Regulatory Affairs or regulated industries with strong regulatory processes and submissions knowledge.
  • 10 years leading transformation, analytics, digital enablement, or strategic technology initiatives with measurable impact.
  • Experience leading AI, advanced analytics, knowledge management, or digital transformation in regulated environments.
  • Proven ability to translate innovation strategies into operational execution with new technologies.
  • Expertise in change management and driving adoption of new capabilities.
  • Knowledge of regulatory innovation trends, structured content, data-driven regulatory approaches.

Responsibilities

  • Develop and execute a Regulatory Transformation Innovation strategy aligned with GRA objectives and enterprise priorities.
  • Lead end-to-end regulatory practices modernization, including document authoring, workflow automation, and structured content development.
  • Identify and pursue opportunities to enhance regulatory capabilities via AI, analytics, and automation.
  • Assess external trends to guide strategic priorities and capability investments.
  • Oversee governance and value-realization frameworks for transformational opportunities across GRA.
  • Collaborate with cross-functional teams to align initiatives with business priorities and regulatory requirements.
  • Build external partnerships to bring innovative ideas into the organization.
  • Advise senior leaders on innovation opportunities and organizational readiness.
  • Communicate progress and lessons learned to maintain momentum and alignment.

Skills

Regulatory Affairs
Transformation leadership
AI/ML
Analytics
Digital enablement
Change management
Stakeholder engagement
Regulatory innovation

Education

Bachelor’s degree
Advanced degree

Job description

Vertex Pharmaceuticals is seeking a Senior Director of Regulatory Transformation Innovation to lead the modernization of Global Regulatory Affairs processes using digitization, AI/ML, analytics, and automation. This strategic leader will guide initiatives across GRA and partners, delivering measurable business value and a culture of innovation.

The role is hybrid, requiring three or more onsite days per week at the Boston Seaport location, with a focus on transforming regulatory content,

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