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 interactions
- Prepare 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.
