Global Regulatory Strategy Director, Renal (Hybrid)

Vertex Pharmaceuticals LLC; England; Hybrid; GBP 150,000 - 190,000; Full time

Job summary

Vertex Pharmaceuticals LLC in the United Kingdom (Paddington) is seeking a Regulatory Strategy Director for Renal to define and drive regulatory strategies across global programs. This leader will collaborate with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, and Commercial teams to shape development plans and support business objectives.

The role requires strategic regulatory expertise, strong judgment, and the ability to influence across functions, lead health authority

Qualifications

• Advanced degree in a scientific, medical, or health-related field is preferred; bachelor’s degree required.
• Significant experience in regulatory affairs within the biopharmaceutical industry.
• Experience with global regulatory strategy for development-stage and/or marketed products.
• Experience in renal, nephrology, rare disease, or specialty therapeutic areas is preferred.

Responsibilities

• Lead the development and execution of global regulatory strategies for renal therapy programs across all phases of development.
• Serve as the regulatory representative on cross-functional program teams, providing strategic input to development plans and milestone planning.
• Drive regulatory strategy and execution for major submissions, including INDs/CTAs, NDAs, BLAs, MAAs, supplements, variations, and other post-approval filings.
• Lead planning, preparation, and execution of health authority interactions, including meeting strategy and agency responses.
• Provide regulatory guidance on product development, labeling strategy, expedited pathways, pediatric plans, orphan drug designations and regional registration requirements.
• Partner with Regulatory Operations to ensure high-quality, compliant, and timely submissions.

Skills

Regulatory strategy

Cross-functional leadership

Leadership

Communication

Regulatory submissions

Strategic thinking

Education

Advanced degree

Regulatory affairs experience

Job description

Vertex Pharmaceuticals LLC in the United Kingdom (Paddington) is seeking a Regulatory Strategy Director for Renal to define and drive regulatory strategies across global programs. This leader will collaborate with Clinical Development, Nonclinical, CMC, Safety, Medical Affairs, and Commercial teams to shape development plans and support business objectives.

The role requires strategic regulatory expertise, strong judgment, and the ability to influence across functions, lead health authority