Senior Manager, Regulatory Affairs Cmc

CSL Seqirus

Holly Springs, NC, USA
**
Global regulatory cmc strategy leadership
Biologics product portfolio management
Regulatory submission authoring and review
** CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC for its hybrid roles in Holly Springs, NC, Broadmeadows, Australia, or Liverpool, UK. The ideal candidate will have over five years of regulatory experience in the biologics or plasma industry, with strong expertise in managing regulatory submissions and compliance. **

Job Summary

  • The role involves defining global regulatory strategies to support the development and lifecycle management of biological products.
  • Candidates will represent CSL in official regulatory capacities, acting as an authorized person in interactions with health authorities.
  • The position requires partnering closely with R&D, Manufacturing, and Quality stakeholders to deliver timely regulatory solutions.

Matching Summary

Match Score: 75

** CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC for its hybrid roles in Holly Springs, NC, Broadmeadows, Australia, or Liverpool, UK. The ideal candidate will have over five years of regulatory experience in the biologics or plasma industry, with strong expertise in managing regulatory submissions and compliance. **

Skills & Requirements

Must-have

  • Global regulatory CMC strategy leadership
  • Biologics product portfolio management
  • Regulatory submission authoring and review
  • Change control assessment execution
  • Health authority interaction representation

Nice-to-have

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

Key Requirements

  • Bachelor's degree in biological or chemical sciences
  • Over 5 years experience in biologics regulatory roles
  • Advanced degree (MS, PhD) strongly preferred
  • In-depth knowledge of global drug regulations

Work Rights

Not specified

Tailored Resume

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