Senior Manager, Regional Regulatory Lead - US (Hematology)

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

Job summary

CSL Research & Development in the US Hematology space seeks a Senior Manager, Regional Regulatory Lead to guide US regulatory strategy for development and marketed products. You will partner with Global Regulatory Leads, Regulatory CMC, and regional commercial teams to navigate FDA pathways and ensure timely submissions.

The role emphasizes risk assessment, cross-functional collaboration, and proactive stakeholder communication within a hybrid structure (onsite in MA or PA).

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science field.
• Advanced degree in related discipline preferred (MS, PhD, MD, DVM, or MBA).
• Minimum seven years in biotech/pharma with regulatory affairs experience.
• At least three years of regulatory activities for developmental products.
• Experience interacting with at least one health authority.

Responsibilities

• Contribute US regulatory expertise to develop and execute global regulatory strategies.
• Develop and maintain relationships with FDA and support health authority interactions.
• Lead or contribute to regional regulatory submissions and core document development.
• Coordinate Module 1 documentation for US regulatory submissions.
• Collaborate with global/regional teams to ensure alignment of regulatory positions.
• Assess regulatory risks and advise on development and approval strategies.
• Provide regulatory intelligence to inform product decisions and timelines.
• Drive timely completion of regional regulatory deliverables and communicate strategies to stakeholders.

Skills

Regulatory strategy

FDA/regulatory authority interactions

Cross-functional collaboration

Regulatory risk assessment

Strategic thinking

Education

Bachelor's degree in life sciences

Advanced degree (MS/PhD/MD/MBA)

Job description

Senior Manager, Regional Regulatory Lead - US Hematology

CSL Research & Development

Location: King of Prussia, PA or Waltham, MA

Work Arrangement: Hybrid - three days onsite per week

Reports To: Executive Director, Head of Regulatory

CSL'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 regulatory strategies and decisions to relevant regional commercial stakeholders.
• Stakeholder Relationships: Build strong working relationships across global and regional regulatory teams, ensuring effective communication, alignment, and collaboration throughout the product lifecycle.

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science field required.
• Advanced degree in a related discipline, such as an MS, PhD, MD, DVM, or MBA, preferred.
• Minimum of seven years of experience in the biotechnology or pharmaceutical industry, including at least five years of regulatory affairs experience.
• At least three years of experience supporting regulatory activities for developmental products.
• Experience working in Regulatory Affairs with responsibility for interaction with at least one health authority.
• Developing knowledge of pharmaceutical or biological product development and regulatory requirements for development and approval in a major region, such as the US, EU, or Japan.
• Experience working within cross-functional teams and matrixed reporting structures.
• Ability to evaluate options, exercise sound judgment, and make informed decisions in complex situations.

The expected base salary range for this position at hiring is $150,000 - $180,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

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