Global Regulatory Strategy Director - Hybrid

CSL; King of Prussia (PA); Hybrid; USD 242,000 - 270,000; Full time

Job summary

CSL is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to drive science-based regulatory strategies for assigned products across the lifecycle.

The role partners with product strategy, clinical development, safety, and commercial teams, ensuring regulatory considerations shape development decisions. You will lead health authority engagements with FDA/EMA, guide cross-functional teams, and mentor regional leads.

Qualifications

• Bachelor's degree in life sciences required; advanced degree preferred.
• Experience in regulatory affairs across US/EU/Japan regions beneficial.
• Proven leadership of cross-functional regulatory teams and strategic initiatives.

Responsibilities

• Develop and lead global regulatory strategies across product lifecycles.
• Serve as primary GRA representative on product strategy teams and cross-functional groups.
• Lead health authority engagement with FDA/EMA to influence regulatory outcomes.
• Oversee GRA strategy teams, set priorities, and coordinate deliverables.
• Provide regulatory guidance to senior leadership and cross-functional teams.

Skills

Global Regulatory Strategy

Regulatory leadership

Stakeholder engagement

Cross-functional collaboration

Strategic thinking

Education

Bachelor's degree in Life Sciences

MS/PhD preferred

Job description

CSL is seeking a Director, Senior Global Regulatory Lead (Sr. GRL) to drive science-based regulatory strategies for assigned products across the lifecycle.

The role partners with product strategy, clinical development, safety, and commercial teams, ensuring regulatory considerations shape development decisions. You will lead health authority engagements with FDA/EMA, guide cross-functional teams, and mentor regional leads.