About the job
An exciting opportunity has arisen to join the CSL Seqirus in-licensed products team as a senior regulatory leader. This position is crucial for developing expert regulatory strategies and preparing complex submissions to regulatory authorities, ultimately impacting the introduction of innovative therapies in Australia and New Zealand. The team thrives in a collaborative environment, sharing experiences and learning from each other while working cross-functionally with various internal teams and international partners.
You'll be responsible for
📈
Developing and executing regulatory strategies
Creating innovative strategies to achieve successful regulatory outcomes aligned with business goals.📝
Planning and submitting high-quality applications
Preparing and submitting applications in Australia/New Zealand, including regulatory authority briefing documentation and responses to evaluation reports.🤝
Collaborating cross-functionally
Working with medical, safety, and commercial teams to develop high-quality materials tailored to the Australian and New Zealand markets.Key criteria
📜
Regulatory experience in ANZ
Extensive experience with prescription medicines in Australia and New Zealand.View
📝
Submission and registration expertise
Proven experience in innovator medicines submissions and registrations.View
🤝
Negotiation skills
Demonstrated ability to negotiate with TGA and Medsafe effectively.View
View more
