CSL este o companie globală de biotehnologie și servicii medicale care dezvoltă produse bioterapeutice și vaccinuri pentru persoanele care trăiesc cu boli grave și rare. Operațiunile sale includ CSL Behring, care oferă tratamente pentru imunodeficiență, tulburări ereditare de coagulare și deficit de alfa-1 antitripsină; CSL Seqirus, un furnizor important de vaccinuri antigripale; și CSL Vifor, axată pe deficitul de fier și nefrologie. Susținută de o rețea extinsă de cercetare și dezvoltare, CSL activează în domeniul fracționării plasmei, al tehnologiei proteinelor recombinante, al terapiilor celulare și genice și al vaccinurilor. Cu sediul în Melbourne, Australia, compania deservește pacienți din peste 100 de țări și oferă oportunități de carieră în cercetare, producție, servicii medicale și biotehnologie.
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.
Descriere
- 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
Cerințe
- 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
Beneficii
- Total compensation may include incentive compensation
- Total compensation may include equity
- Reasonable accommodation is available during the application process for individuals with disabilities