Senior Manager, Regulatory Affairs Cmc

CSL Seqirus

Holly Springs, NC, USA
Hybrid
Global regulatory cmc strategy leadership
Biologics and non-biological product submissions
Change control assessment and compliance
The role involves defining global regulatory strategies to support the development, registration, and lifecycle management of biological and non-biological products

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.
  • Joining this agile team means contributing to the development of vaccines that make a meaningful difference worldwide.

Matching Summary

The role involves defining global regulatory strategies to support the development, registration, and lifecycle management of biological and non-biological products.

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • Biologics and non-biological product submissions
  • Change control assessment and compliance

Nice-to-have

  • Cross-functional collaboration with R&D
  • Innovative regulatory approaches
  • Strong relationship management with regulators

Key Requirements

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

Work Rights

Not specified

Tailored Resume

Cover Letter