Director Regulatory Affairs ANZ

CSL is a global leader in biotechnology, dedicated to advancing and protecting public health. We are seeking an experienced Director Regulatory Affairs 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.

Your Responsibilities

Reporting to the RA/ PV Cluster Head APAC, GRAS and based at CSL Melbourne headquarters, key responsibilities in this critical role include:

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, represent CSL in relevant meetings and forums, and share insights and best practices across the organisation.Serve as the primary interface with Health Authorities, government bodies, industry associations, and local commercial teams, leading in‑country regulatory processes and market access‑related interactionsPrepare and coordinate local regulatory documentation (e.g., Module 1 and briefing materials), maintain required national systems, support regional teams, and monitor local Health Authority activities.Ensure compliant labelling, timely updates, promotional material review, accurate records, and adherence to compliance KPIs

Your Skills

To be successful in this role you will bring:

Bachelor’s degree in a relevant scientific discipline (e.g., biology, chemistry) with advanced degrees (Master’s or PhD) preferred.Regional regulatory certifications (RAC, CARP, CHPC) are desirable.10+ years of regulatory experience with significant Health Authority facing responsibilities.Strong leadership background with experience guiding regulatory teams.Expertise in Australian and New Zealand regulatory frameworks and external engagement.Proven ability to manage regulatory submissions, cross‑functional initiatives, and complex timelines.

If you are a seasoned regulatory leader with deep Australian regulatory expertise and a passion for meaningful impact, we invite you to apply and help shape CSL’s future.