Not specified; not specified; benefits available v...
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Global regulatory cmc strategy leadership
Biologics and non-biological product registration
Regulatory submission authoring and management
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CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to lead global regulatory strategies and compliance for their product portfolio. This hybrid position requires a strong background in regulatory roles, particularly in the biologics or plasma industry, and offers a dynamic work environment focused on pandemic preparedness and vaccine development.
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Job Summary
The role involves defining global regulatory strategies to support the development and lifecycle management of CSL's biological and non-biological product portfolios.
Candidates will act as an authorized official representing CSL in interactions with regulatory agencies to ensure timely responses and guidance from health authorities.
This hybrid position requires working onsite three days a week at one of the company's major hubs in Holly Springs, Broadmeadows, or Liverpool.
Matching Summary
Match Score: 75
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CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to lead global regulatory strategies and compliance for their product portfolio. This hybrid position requires a strong background in regulatory roles, particularly in the biologics or plasma industry, and offers a dynamic work environment focused on pandemic preparedness and vaccine development.
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Salary
Not specified; Not specified; Benefits available via CSL Well-being program
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
Biologics and non-biological product registration
Regulatory submission authoring and management
Change control assessment in quality systems
Interaction with international regulatory agencies
Nice-to-have
Strategic problem solving and contingency planning
Cross-functional collaboration with R&D and Quality
Innovative regulatory approaches for competitive positioning
Strong relationship management with health authorities
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years progressive experience in biologics or plasma industry
Advanced degree (MS, PhD) strongly preferred
In-depth knowledge of global drug regulations and standards