Senior Global Regulatory Strategy Leader

CSL; Maidenhead; Hybrid; GBP 180,000 - 200,000; Full time

Job summary

CSL Maidenhead, UK, is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to shape global regulatory strategy across the product lifecycle.

In this high‑visibility role you’ll partner with health authorities and cross‑functional teams to align regulatory plans with development milestones. You will lead Global Regulatory Strategy activities, drive engagement with the FDA and EMA, develop key regulatory deliverables, and mentor regional leads within a global, matrixed organization to

Qualifications

• Minimum 10 years in biotech/pharma with 8+ years in Regulatory Affairs.
• 5+ years supporting pharmaceutical or biological product development.
• 5 years direct or matrix leadership experience.
• Strong knowledge of global regulatory requirements (US/EU/Japan).
• Experience with major health authorities (FDA/EMA).
• Experience navigating global, matrixed organizations.

Responsibilities

• Develop and lead global regulatory strategies for assigned products across lifecycle.
• Serve as primary GRA representative on Product Strategy Teams and cross-functional groups.
• Lead health authority engagement with FDA/EMA and global partners.
• Oversee the GRA Strategy Team: set priorities, coordinate deliverables, assign responsibilities.
• Provide regulatory guidance to senior leadership and teams.
• Lead regulatory deliverables: Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans.
• Drive regulatory intelligence and innovation to inform strategy.
• Promote global regulatory alignment with regional teams and CMC.
• Coach and develop Regional Regulatory Leads where applicable.

Skills

Global Regulatory Strategy

Regulatory leadership

Health authority engagement

Cross-functional collaboration

Strategic thinking

Communication

Education

Bachelor's degree in life sciences

Advanced degree preferred

Job description

CSL Maidenhead, UK, is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to shape global regulatory strategy across the product lifecycle.

In this high‑visibility role you’ll partner with health authorities and cross‑functional teams to align regulatory plans with development milestones. You will lead Global Regulatory Strategy activities, drive engagement with the FDA and EMA, develop key regulatory deliverables, and mentor regional leads within a global, matrixed organization to