Senior Manager, US Hematology Regulatory Strategy

CSL; Philadelphia (Philadelphia County); Hybrid; USD 150,000 - 180,000; Full time

Job summary

CSL is seeking a Senior Manager, Regional Regulatory Lead – US Hematology, to join the Global Regulatory Strategy within Global Regulatory Affairs. The role focuses on US regulatory leadership, FDA interactions, and submissions for investigational, new, and marketed products.

You will partner with global and regional teams to ensure compliant, timely regulatory decisions and strategic alignment across product lifecycles.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science field.
• Advanced degree preferred (MS, PhD, MD, DVM, MBA).
• 7+ years in biotech/pharma with 5+ years regulatory affairs experience.
• 3+ years supporting regulatory activities for developmental products.
• Experience interacting with at least one health authority.
• Knowledge of US FDA regulatory requirements and development pathways.

Responsibilities

• Contribute US regulatory strategy to global regulatory plans.
• Develop and maintain FDA engagement and negotiations.
• Lead or contribute to regulatory submissions for investigational, new, and marketed products.
• Oversee US Module 1 documentation and responses to agency comments.
• Collaborate with Global Regulatory Leads and cross-functional teams.
• Assess regulatory risks and opportunities for development programs.
• Communicate regulatory strategy to regional commercial stakeholders.

Skills

Regulatory strategy

FDA engagement

Regulatory submissions

Cross-functional collaboration

Risk assessment

Education

Bachelor's degree in life sciences

MS/PhD/MD/DVM/MBA preferred

Job description

CSL is seeking a Senior Manager, Regional Regulatory Lead – US Hematology, to join the Global Regulatory Strategy within Global Regulatory Affairs. The role focuses on US regulatory leadership, FDA interactions, and submissions for investigational, new, and marketed products.

You will partner with global and regional teams to ensure compliant, timely regulatory decisions and strategic alignment across product lifecycles.