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GRA CMC Specialist

Mid levelSeniorFull-timeHybrid189-209 Camp Rd, Broadmeadows VIC 3047, Australia655 Elizabeth St, Melbourne VIC 3000, AustraliaPosted 1 day agoVerified 3 weeks ago
Pending fitX of Y criteria met

About the job

The Team Lead, Global Regulatory Affairs is a pivotal position responsible for driving regulatory strategies for CSL’s biological and non-biological products. This job plays a crucial role in ensuring compliance and fostering collaboration across various teams to support innovative solutions. The team values strong communication and a proactive approach to navigating regulatory challenges.

You'll be responsible for

🌍

Leading regulatory strategy

Leading the global regulatory CMC strategy for biological and non-biological products, collaborating with cross-functional leaders.
📄

Managing regulatory submissions

Managing the development and submission of high-quality, compliant CMC regulatory submissions aligned with business goals.
🤝

Building relationships with regulators

Representing CSL in official regulatory capacities and maintaining strong relationships with regulatory agencies.

Key criteria

📜

Regulatory submission expertise

Proven experience authoring and managing regulatory submissions.

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🌍

Global regulatory knowledge

In-depth knowledge of international regulations for drug development.

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🤝

Cross-functional collaboration

Demonstrated ability to lead and collaborate with diverse teams.

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Meet the team

About the company

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5 criteria for this job
Regulatory submission expertise
Proven experience authoring and managing regulatory submissions.

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Global regulatory knowledge
In-depth knowledge of international regulations for drug development.

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Cross-functional collaboration
Demonstrated ability to lead and collaborate with diverse teams.

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Strategic planning experience
Experience developing regulatory strategies aligned with business goals.

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Effective communication skills
Exceptional oral and written communication with regulatory stakeholders.

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