About the job
The Senior Manager, Regulatory Affairs CMC at CSL Seqirus is a pivotal job that focuses on developing and implementing regulatory strategies for innovative vaccine products. This position plays a crucial role in ensuring compliance and advancing product registration while fostering collaboration across various teams. The team thrives on agility and innovation, working together to make a meaningful impact in global health.
You'll be responsible for
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Leading global regulatory CMC strategy
Overseeing the regulatory CMC strategy for assigned biological and non-biological product portfolios, ensuring alignment with business goals.📑
Managing regulatory submissions
Developing and submitting compliant CMC regulatory submissions, including marketing applications and clinical trial applications, ensuring timely execution.📞
Representing CSL in regulatory interactions
Acting as an authorized official in communications with regulatory agencies, maintaining strong relationships and ensuring timely responses.Key criteria
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Bachelor’s degree in relevant field
Possession of a degree in biological or chemical sciences is essential.View
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5+ years in regulatory roles
Demonstrated experience in regulatory affairs within biologics or plasma.View
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Expertise in regulatory submissions
Proven ability to author and manage regulatory submissions accurately.View
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