Senior Manager, Regulatory Affairs Cmc

CSL Seqirus

Holly Springs, NC, USA
**
Global regulatory cmc strategy leadership
Biologics and non-biological product experience
Authoring compliant regulatory submissions
** CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC, responsible for developing and executing regulatory strategies for biological and non-biological products. The position is hybrid, requiring three days onsite, and involves collaboration with multiple stakeholders to ensure compliance and timely submissions. **

Job Summary

  • The role involves defining global regulatory strategies to support the development and lifecycle management of CSL's biological and non-biological products.
  • Candidates will act as an authorized official representing CSL in interactions with regulatory agencies to ensure timely responses and guidance.
  • This hybrid position requires being onsite three days a week while collaborating with R&D, Manufacturing, and Quality stakeholders.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC, responsible for developing and executing regulatory strategies for biological and non-biological products. The position is hybrid, requiring three days onsite, and involves collaboration with multiple stakeholders to ensure compliance and timely submissions. **

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • Biologics and non-biological product experience
  • Authoring compliant regulatory submissions
  • Change control assessment expertise
  • Regulatory agency interaction management

Nice-to-have

  • Strategic problem solving skills
  • Cross-functional collaboration abilities
  • Innovative regulatory approaches
  • Strong relationship building with regulators

Key Requirements

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

Work Rights

Not specified

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