Senior Manager, Regulatory Affairs Cmc

CSL Seqirus

Holly Springs, North Carolina, United States
Hybrid (3 days onsite)
Global regulatory cmc strategy leadership
Biologics and non-biologic product portfolio management
Regulatory submission authoring and review
CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to join their hybrid team in Holly Springs, NC, Broadmeadows, Australia, or Liverpool, UK. The role involves leading global regulatory strategies and ensuring compliance for biological and non-biological products, collaborating with various internal and external stakeholders

Job Summary

  • CSL Seqirus is a global leader in influenza prevention and the world's second-largest influenza vaccine provider.
  • The role involves defining global regulatory strategies to advance the development, registration, and lifecycle management of biological and non-biological products.
  • This hybrid position requires onsite work three days a week at locations in Holly Springs, NC; Broadmeadows, Australia; or Liverpool, UK.

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to join their hybrid team in Holly Springs, NC, Broadmeadows, Australia, or Liverpool, UK. The role involves leading global regulatory strategies and ensuring compliance for biological and non-biological products, collaborating with various internal and external stakeholders.

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • Biologics and non-biologic product portfolio management
  • Regulatory submission authoring and review
  • Change control assessment in quality management system
  • Interaction with regulatory agencies as authorized official

Nice-to-have

  • Strategic problem solving and contingency planning
  • Cross-functional collaboration with R&D and Quality
  • Innovative regulatory approaches for competitive positioning

Key Requirements

  • Bachelor's degree in biological or chemical sciences required
  • Advanced degree (MS, PhD) strongly preferred
  • Over 5 years progressive experience in biologics or plasma industry regulatory roles

Work Rights

Not specified

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