About the job
Join CSL Seqirus as a Regulatory Affairs Manager and embark on a journey that impacts health across the Asia Pacific region. This job is all about owning regional regulatory strategies and engaging meaningfully with Health Authorities to ensure compliance and successful submissions. The team thrives in a collaborative and dynamic environment, where innovation and support for career growth are at the forefront.
You'll be responsible for
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Driving regulatory strategy
Drive and implement APAC regulatory strategy for CSL Seqirus manufactured products, including development activities and complex technical/lifecycle changes.đ
Leading submissions
Lead regional regulatory input to dossiers and submissions, including direct interaction and negotiation with Health Authorities.â
Ensuring compliance
Ensure regulatory compliance and traceability via appropriate management of submissions and agency correspondence.Key criteria
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7+ years in regulatory affairs
Demonstrated experience in regulatory affairs, especially in Asia Pacific.View
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Experience with Health Authorities
Proven track record negotiating and engaging with local Health Authorities.View
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Submission preparation expertise
Experience preparing high-quality regulatory submissions for approval.View
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