Director, Local Regulatory Representative Lead (ANZ)
CSL · Melbourne, Victoria, AU
CSL is a global leader in biotechnology, dedicated to advancing and protecting public health. We are seeking an experienced Director, Local Regulatory Repres...
Job description
CSL is a global leader in biotechnology, dedicated to advancing and protecting public health. We are seeking an experienced Director, Local Regulatory Representative Lead for Australia and New Zealand (ANZ) to play a critical leadership role within Global Regulatory Affairs & Safety (GRAS) APAC Affiliate Cluster. This is a high‑impact position responsible for guiding national regulatory operations, shaping local strategy, and representing CSL in key interactions with Health Authorities and industry bodies. This role will report to RA/ PV Cluster Head APAC, GRAS. Your Responsibilities: - Collaborate with colleagues in Therapeutic Area teams on regulatory strategy decision‑making, ensure regulatory operations, and act as the first point of escalation for challenges. - Provide expert local insights to develop and execute regulatory strategies for new product registrations and lifecycle management, monitoring and communicating progress to stakeholders. - Ensure compliance with ANZ regulatory requirements, contribute to local policy and industry group activities, and support audit/inspection readiness and CAPA completion. - Stay informed on evolving national regulations and guidelines,...