Senior Manager, Regional Regulatory Lead - US; Hematology

Position: Senior Manager, Regional Regulatory Lead - US (Hematology)
Senior Manager, Regional Regulatory Lead – US HematologyCSL Research & Development

Location:

King of Prussia, PA or Waltham, MAWork Arrangement:
Hybrid – three days onsite per week

Reports To:

Executive Director, Head of RegulatoryCSL’s Research & Development organization is accelerating innovation to deliver greater impact for patients. Through a project-led structure and a focus on collaboration, we are building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL means becoming part of an agile organization committed to developing innovative therapies that make a meaningful difference for patients worldwide.

Position Overview CSL is seeking a Senior Manager, Regional Regulatory Lead – US Hematology to join Global Regulatory Strategy (GRS) within Global Regulatory Affairs (GRA). This individual will contribute regional regulatory expertise to the development and execution of integrated global regulatory strategies for assigned products, with a focus on the US market and FDA requirements.

The Regional Regulatory Lead (RRL) partners closely with Global Regulatory Leads (GRLs), cross-functional regulatory teams, Regulatory CMC, and commercial stakeholders to support regulatory strategy, product development, submissions, and health authority interactions. This role requires strong regulatory knowledge, sound judgment, effective cross-functional collaboration, and the ability to navigate a complex, matrixed organization to achieve timely and successful regulatory outcomes.

The successful candidate will serve as a regional regulatory expert, provide guidance on US regulatory requirements and pathways, and help identify opportunities and mitigate risks across developmental, new, and marketed products.

Key Responsibilities Regional Regulatory Strategy:
Contribute US regulatory expertise to the development and execution of integrated global regulatory strategies for assigned products, ensuring alignment with global objectives, regional requirements, commercial insights, and patient needs.

Health Authority Engagement:
Develop and maintain productive relationships with the FDA and support or lead assigned health authority interactions and negotiations in partnership with the Global Regulatory Lead and Regulatory Therapeutic Area leadership.

Regulatory Submissions:
Lead or contribute to regional regulatory activities for investigational, new, and marketed products, including submission preparation, core document development, briefing books, pediatric plans, and other regulatory deliverables.

US Submission Documentation:
Oversee the preparation and coordination of required Module 1 documentation for US regulatory submissions and support responses to health authority questions and comments.

Cross-Functional Collaboration:

Partner with Global Regulatory Leads, Global Regulatory Affairs Strategy Team (GRAST) members, Regulatory CMC, regional commercial operations, and other stakeholders to ensure consistent regulatory positions, informed decision-making, and effective execution of regulatory plans.

Regulatory Guidance and Risk Assessment:
Provide regional expertise on FDA requirements, regulatory pathways, filing categories, processes, and ways of working. Assess regulatory risks, identify opportunities, and advise internal stakeholders on approaches to address development and approval challenges.

Regulatory Strategy and Intelligence:
Contribute to regulatory strategy development, cross-functional document reviews, and competitive regulatory intelligence to inform product decisions and support successful regulatory outcomes.

Execution and Communication:
Drive timely completion of regional regulatory deliverables, promote accountability across project teams, and communicate global…