Director, Local Regulatory Representative Lead (ANZ)
CSL
Melbourne
3 days ago
Director, Local Regulatory Representative Lead (ANZ)
CSL seeks a Director, Local Regulatory Representative Lead for ANZ to lead regulatory operations in Australia and New Zealand. The role requires 10+ years of regulatory experience, deep ANZ regulatory knowledge, and strong leadership skills. The position is based in Melbourne, Australia, on-site.
On-site
Full-time
Director
Salary
Not specified
Core Qualifications
Soft Skills
leadershipstrategic thinkingcommunicationcollaboration
Key Responsibilities
- Collaborate with Therapeutic Area teams on regulatory strategy decision-making and act as first point of escalation.
- Provide expert local insights to develop and execute regulatory strategies for new product registrations and lifecycle management.
- Ensure compliance with ANZ regulatory requirements, contribute to local policy and industry group activities, and support audit/inspection readiness.
- Stay informed on evolving national regulations and guidelines, represent CSL in relevant meetings and forums.
- Serve as primary interface with Health Authorities, government bodies, industry associations, and local commercial teams.
- Prepare and coordinate local regulatory documentation (e.g., Module 1 and briefing materials), maintain national systems.
- Ensure compliant labelling, timely updates, promotional material review, and adherence to compliance KPIs.
DirectorRegulatory AffairsANZAustraliaNew ZealandBiotechnologyLeadershipHealth AuthorityFull-timeOn-site