Regulatory Strategy Director, Renal

Overview

In this role you will lead global regulatory strategy for Vertex’s renal therapy programs, guiding development across all phases and aligning with global objectives. You will serve as the regulatory expert on cross-functional teams, shaping plans with Clinical, Nonclinical, CMC, Safety, Medical Affairs, and Commercial functions. You will manage health authority interactions, submissions, and lifecycle activities to advance investigational assets and marketed products. Your leadership will influence governance forums and drive compliant, timely regulatory actions in a fast-paced, science-driven environment.

Pay / Benefits

• hybrid work model (remote up to two days per week)
• on-site option
• flexible work arrangements
• reasonable accommodations for disabilities
• employee-focused policies
• E-Verify employer status

Responsibilities

• Lead global regulatory strategies for renal therapy programs across all development phases
• Act as regulatory representative on cross-functional program teams to inform development plans and milestones
• Drive regulatory submissions (INDs/CTAs, NDAs, BLAs, MAAs, supplements, variations, post-approval filings)
• Plan and execute health authority interactions, including meeting strategy and agency responses
• Provide regulatory guidance on labeling, expedited pathways, pediatric plans, orphan designations and regional registrations
• Collaborate with Regulatory Operations and SMEs to ensure high-quality, timely submissions
• Assess regulatory risks and communicate recommendations to leadership
• Support lifecycle management (new indications, formulation changes, manufacturing updates)
• Monitor evolving global regulations and competitive developments related to renal programs
• Contribute to regulatory process improvements and best practices
• Mentor and develop regulatory team members and foster a collaborative culture

Key requirements

• Deep understanding of global regulatory requirements and drug development processes across major markets
• Ability to develop and communicate clear, actionable regulatory strategy
• Strong leadership and influencing skills in a matrixed, cross-functional environment
• Experience leading complex regulatory submissions and agency interactions
• Excellent written and verbal communication, with ability to present to senior leadership
• Strong organizational skills and ability to manage multiple priorities with attention to detail
• Sound judgment, agility, and proactive problem-solving mindset

• leadership
• collaboration
• clear communication
• global regulatory strategy
• regulatory submissions (INDs/CTAs, NDAs, BLAs, MAAs)
• health authority interactions

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