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-biological product submissions
Regulatory agency interaction and representation
CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to lead global regulatory strategies for its biological and non-biological product portfolios. The ideal candidate should have extensive experience in regulatory roles, particularly within the biologics or plasma industries, and the position offers a hybrid work arrangement with a strong emphasis on collaboration and compliance

Matching Summary

Match Score: 85

CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to lead global regulatory strategies for its biological and non-biological product portfolios. The ideal candidate should have extensive experience in regulatory roles, particularly within the biologics or plasma industries, and the position offers a hybrid work arrangement with a strong emphasis on collaboration and compliance.

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • Biologics and non-biological product submissions
  • Regulatory agency interaction and representation
  • Change control assessment in quality management
  • Cross-functional collaboration with R&D and Quality

Nice-to-have

  • Innovative regulatory approaches for competitive positioning
  • Strong relationship management with health authorities
  • Strategic problem solving and contingency planning
  • Evaluation of new business opportunities
  • Agile team commitment to meaningful impact

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
  • In-depth knowledge of global drug development regulations

Work Rights

Not specified

Tailored Resume

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