Head of Nonclinical Programs & Regulatory Submissions

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 156,000 - 234,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated is seeking an Associate Director for Nonclinical Sciences Program Management & Strategic Operations. You will integrate and drive complex development programs, coordinating with Regulatory Affairs and external partners to ensure milestones are met on time and within budget.

You will lead regulatory submission planning and execution for NDA/BLA and IND/CTA efforts, while partnering with cross-functional SMEs to coordinate content readiness and post‑marketing

Qualifications

• Bachelor's degree in a scientific discipline is required.
• Typically 10+ years of pharma/biotech experience in nonclinical drug development.
• Experience coordinating NDA/BLA submissions and regulatory activities.

Responsibilities

• Lead program mgmt and operations for nonclinical development programs.
• Plan and track regulatory submissions and timelines across NDA/BLA and IND/CTA.
• Coordinate cross-functional authoring, review, and submission readiness.
• Communicate progress, risks, and mitigation strategies to leadership.

Skills

GLP regulations

Nonclinical development

Regulatory submissions

Cross-functional leadership

Project management

Communication skills

Risk management

Education

Bachelor's degree in a scientific discipline

Tools

Project management tools

Job description

Vertex Pharmaceuticals Incorporated is seeking an Associate Director for Nonclinical Sciences Program Management & Strategic Operations. You will integrate and drive complex development programs, coordinating with Regulatory Affairs and external partners to ensure milestones are met on time and within budget.

You will lead regulatory submission planning and execution for NDA/BLA and IND/CTA efforts, while partnering with cross-functional SMEs to coordinate content readiness and post‑marketing