Role OverviewThe Team Lead, Global Regulatory Affairs CMC is responsible for partnering with CSL's R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions. This role promotes strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions.
What You Will Do
The main responsibilities of this role include leading the global regulatory CMC strategy, managing the development and submission of high-quality, compliant CMC regulatory submissions, and ensuring accurate and timely change control assessments.
Why It Might Be a Fit
This role requires a strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management. The ideal candidate will have proven expertise in authoring, reviewing, and managing regulatory submissions, and demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders.
Requirements
- A bachelor's degree in biological or chemical sciences, or a related field
- Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry
- Strong technical foundation with in-depth knowledge of global regulations and international standards
- Proven expertise in authoring, reviewing, and managing regulatory submissions
- Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders
Benefits
- Dental insurance
- Vision insurance
- Health insurance
- Retirement plan
- Paid time off
- Wellness programs
- Professional development opportunities
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