The role involves leading global regulatory CMC strategy across the assigned development and commercial product portfolio while collaborating with cross-functional leaders
Job Summary
The role involves leading global regulatory CMC strategy across the assigned development and commercial product portfolio while collaborating with cross-functional leaders.
Candidates will be responsible for managing high-quality, compliant CMC regulatory submissions including new marketing applications and periodic compliance reports.
Joining CSL Seqirus means being part of an agile team committed to developing vaccines that make a meaningful difference worldwide.
Matching Summary
The role involves leading global regulatory CMC strategy across the assigned development and commercial product portfolio while collaborating with cross-functional leaders.
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
Strategic problem solving abilities
Cross-functional collaboration skills
Innovative regulatory approaches
Strong relationship building with regulators
Key Requirements
Bachelor's degree in biological or chemical sciences required
Over 5 years progressive experience in biologics or plasma industry
MS or PhD strongly preferred
Hybrid work model requiring onsite presence three days per week