Not specified; not specified; benefits not detaile...
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Global regulatory cmc strategy leadership
Biologics or plasma industry experience
Authoring compliant regulatory submissions
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CSL Seqirus is seeking a Senior Manager for Regulatory Affairs CMC to lead global regulatory strategies for their biological and non-biological product portfolio. The role requires extensive experience in regulatory roles, particularly in the biologics or plasma industry, and offers a hybrid work environment.
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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 represent CSL as an authorized official in interactions with regulatory agencies and maintain strong relationships with health authorities.
This hybrid position requires being onsite three days a week while collaborating with R&D, Manufacturing, Quality, and Global Operations stakeholders.
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 for their biological and non-biological product portfolio. The role requires extensive experience in regulatory roles, particularly in the biologics or plasma industry, and offers a hybrid work environment.
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Salary
Not specified; Not specified; Benefits not detailed
Skills & Requirements
Must-have
Global regulatory CMC strategy leadership
Biologics or plasma industry experience
Authoring compliant regulatory submissions
Change control assessment expertise
Regulatory agency interaction management
Nice-to-have
Advanced degree in biological sciences
Innovative regulatory approach implementation
Cross-functional collaboration skills
Strategic business opportunity evaluation
Key Requirements
Bachelor's degree in biological or chemical sciences
Over 5 years progressive regulatory experience in biologics