CSL is a global biotechnology and healthcare company developing biotherapeutics and vaccines for people living with serious and rare diseases. Its operations include CSL Behring, which provides treatments for immunodeficiency, hereditary bleeding disorders, and Alpha-1 Antitrypsin Deficiency; CSL Seqirus, a major influenza vaccine provider; and CSL Vifor, focused on iron deficiency and nephrology. Supported by a broad research and development network, CSL works across plasma fractionation, recombinant protein technology, cell and gene therapy, and vaccines. Headquartered in Melbourne, Australia, the company serves patients in more than 100 countries and offers career opportunities across research, manufacturing, healthcare, and biotechnology.
Senior Manager, US Regional Regulatory Lead – Hematology
Lead US regulatory strategy, submissions, and FDA engagement for CSL Behring’s hematology biotherapeutics. Hybrid position based in King of Prussia, Pennsylvania, or Waltham, Massachusetts.
United States
Massachusetts
Pennsylvania$150,000 – $180,000 / year
HybridFull-timeSeniorEnglish RequiredComplianceDescription
- Apply US regulatory expertise to integrated global strategies for assigned products
- Build and maintain FDA relationships while supporting or leading health authority interactions and negotiations
- Lead or support regional regulatory activities for investigational, new, and marketed products
- Prepare submission materials, core documents, briefing books, pediatric plans, and related regulatory deliverables
- Oversee the preparation and coordination of required Module 1 documentation for US submissions
- Help develop responses to health authority questions and comments
- Collaborate with Global Regulatory Leads, Regulatory Affairs, Regulatory CMC, commercial operations, and other stakeholders
- Advise on FDA requirements, regulatory pathways, filing categories, processes, and operating practices
- Evaluate regulatory risks, identify opportunities, and advise stakeholders on development and approval challenges
- Support regulatory strategy development, document reviews, and competitive regulatory intelligence
- Ensure regional regulatory deliverables are completed on time and reinforce accountability across project teams
- Communicate global regulatory strategies and decisions to regional commercial stakeholders
- Develop effective partnerships across global and regional regulatory teams throughout the product lifecycle
Requirements
- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science discipline is required
- At least seven years of experience in the biotechnology or pharmaceutical industry
- At least five years of regulatory affairs experience
- At least three years supporting regulatory activities for development-stage products
- Experience in Regulatory Affairs with responsibility for interacting with at least one health authority
- Working 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 collaborating in cross-functional teams and matrixed reporting structures
- Ability to assess options, apply sound judgment, and make informed decisions in complex situations
- An advanced degree such as an MS, PhD, MD, DVM, or MBA is preferred
Benefits
- Total compensation may include incentive compensation
- Total compensation may include equity
- Reasonable accommodation is available during the application process for individuals with disabilities