US Hematology Regulatory Lead — Senior Manager

CSL; Waltham (MA); Hybrid; USD 150,000 - 180,000; Full time

Job summary

CSL Behring is seeking a Senior Manager, Regional Regulatory Lead – US Hematology to join Global Regulatory Strategy. This role drives US regulatory strategy, supports FDA interactions, and coordinates regional submissions within a cross-functional team.

The successful candidate will work with Global Regulatory Leads and regulatory CMC to align regional plans with global objectives, ensuring timely regulatory outcomes for development and marketed products. Hybrid work arrangement applies.

Qualifications

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science field required.
• Advanced degree in related discipline preferred (MS, PhD, MD, MBA).
• Minimum seven years in biotech/pharma, with at least five years in regulatory affairs.
• At least three years supporting regulatory activities for developmental products.
• Experience interacting with at least one health authority (e.g., FDA).
• Experience in a cross-functional, matrixed environment.

Responsibilities

• Contribute US regulatory expertise to regional/global regulatory strategies.
• Develop and maintain FDA relationships and support health authority interactions.
• Lead or contribute to regional regulatory submissions and document development.
• Coordinate Module 1 documentation for US regulatory submissions.
• Collaborate with global regulatory teams and commercial stakeholders.
• Assess FDA requirements, risks, and pathways for development and approval.
• Support regulatory strategy and intelligence to inform product decisions.
• Ensure timely delivery of regional regulatory deliverables and decisions.

Skills

FDA interactions

US regulatory strategy

Cross-functional collaboration

Regulatory submissions

Team leadership

Regulatory intelligence

Education

Bachelor’s degree in a life science

Advanced degree preferred (MS/PhD/MD/etc.)

Job description

CSL Behring is seeking a Senior Manager, Regional Regulatory Lead – US Hematology to join Global Regulatory Strategy. This role drives US regulatory strategy, supports FDA interactions, and coordinates regional submissions within a cross-functional team.

The successful candidate will work with Global Regulatory Leads and regulatory CMC to align regional plans with global objectives, ensuring timely regulatory outcomes for development and marketed products. Hybrid work arrangement applies.