Senior Global Regulatory Scientist - Strategic Submissions Lead

ICON Clinical Research; Sydney; On-site; AUD 180,000 - 240,000; Full time

Job summary

ICON Clinical Research in Sydney is seeking a Senior Regulatory Scientist to lead global regulatory strategies and drive submissions across clinical programmes. You will mentor colleagues, interact with health authorities, and shape regulatory positions for development programs.

With a strong regulatory affairs background, you will interpret FDA/EMA/ICH requirements, author complex documents, and collaborate cross-functionally.

Qualifications

• Strong foundation in regulatory affairs and the ability to work independently
• Experience navigating FDA/EMA/ICH and global regulatory requirements
• Excellent written and verbal communication with meticulous attention to detail
• Proven ability to mentor colleagues and lead cross-functional regulatory projects

Responsibilities

• Lead development of global regulatory strategies for clinical programmes
• Author and review complex regulatory documents (DAs, briefing books, major submissions)
• Interpret evolving global regulations and advise on programme design
• Provide strategic input to development plans and labeling considerations
• Represent regulatory functions in sponsor and health authority meetings
• Mentor junior regulatory colleagues and contribute to internal best practices

Skills

Regulatory strategy

Regulatory science

Mentoring

Communication

Cross-functional collaboration

Education

Bachelor's degree in a relevant scientific discipline

Job description

ICON Clinical Research in Sydney is seeking a Senior Regulatory Scientist to lead global regulatory strategies and drive submissions across clinical programmes. You will mentor colleagues, interact with health authorities, and shape regulatory positions for development programs.

With a strong regulatory affairs background, you will interpret FDA/EMA/ICH requirements, author complex documents, and collaborate cross-functionally.