Senior Manager, Regulatory Affairs Cmc

CSL Seqirus

Holly Springs, NC, USA
Not specified; not specified; benefits available p...
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Global regulatory cmc strategy leadership
Biologics and non-biological product portfolio management
High-quality compliant regulatory submission authoring
** CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC, responsible for leading global regulatory strategies for their biological and non-biological product portfolio. The role requires over five years of experience in regulatory roles within the biologics or plasma industry and offers a hybrid work environment. **

Job Summary

  • The role involves defining global regulatory strategies to support the development, registration, and lifecycle management of biological and non-biological products.
  • Candidates will represent CSL in official regulatory capacities, acting as an authorized official during interactions with regulatory agencies.
  • This hybrid position requires being onsite three days a week while collaborating with agile teams committed to developing vaccines globally.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC, responsible for leading global regulatory strategies for their biological and non-biological product portfolio. The role requires over five years of experience in regulatory roles within the biologics or plasma industry and offers a hybrid work environment. **

Salary

Not specified; Not specified; Benefits available per company policy

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • Biologics and non-biological product portfolio management
  • High-quality compliant regulatory submission authoring

Nice-to-have

  • Cross-functional collaboration with R&D and Quality
  • Innovative regulatory approaches for competitive positioning
  • Strong relationship management with health authorities

Key Requirements

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

Work Rights

Not specified

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