About the job
The Team Lead, Global Regulatory Affairs is a pivotal position responsible for driving regulatory strategy for CSL’s biological and non-biological products. This job offers the opportunity to collaborate with diverse teams and stakeholders, ensuring compliance while fostering innovation. The team thrives on strong communication and cross-functional collaboration, making a significant impact on the development and lifecycle management of vital therapies.
You'll be responsible for
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Leading global regulatory strategy
Lead the global regulatory CMC strategy across the assigned product portfolio, collaborating with cross-functional leaders.📑
Managing regulatory submissions
Oversee the development and submission of high-quality, compliant CMC regulatory submissions, ensuring timely execution aligned with business goals.🤝
Building relationships with regulators
Represent CSL in official regulatory capacities, maintaining strong relationships with regulators and ensuring timely responses to inquiries.Key criteria
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Regulatory submission expertise
Proven experience in authoring and managing regulatory submissions.View
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Global regulatory knowledge
In-depth knowledge of international regulations for drug development.View
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Cross-functional collaboration
Demonstrated ability to lead and collaborate with diverse teams.View
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