CSL Seqirus is seeking a Senior Manager of Regulatory Affairs CMC to lead global regulatory strategies for biological and non-biological products. The position is hybrid, requiring onsite presence three days a week, and involves close collaboration with various stakeholders to ensure compliance and address regulatory challenges
Job Summary
The role involves defining global regulatory strategies to advance the development and lifecycle management of CSL's biological and non-biological product portfolios.
Candidates will represent CSL in official regulatory capacities as an authorized official during interactions with health authorities worldwide.
This hybrid position requires working onsite three days a week at locations in Holly Springs, NC; Broadmeadows, Australia; or Liverpool, UK.
Matching Summary
Match Score: 85
CSL Seqirus is seeking a Senior Manager of Regulatory Affairs CMC to lead global regulatory strategies for biological and non-biological products. The position is hybrid, requiring onsite presence three days a week, and involves close collaboration with various stakeholders to ensure compliance and address regulatory challenges.
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
Biologics and plasma industry experience
Authoring compliant regulatory submissions
Change control assessment expertise
Regulatory agency interaction management
Nice-to-have
Strategic problem solving abilities
Cross-functional collaboration skills
Innovative regulatory approaches
Strong relationship building with regulators
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years progressive experience in biologics or plasma industry