Senior Global Regulatory Scientist – Remote

KCR Placement; Sydney; Remoto; AUD 150.000 - 210.000; Tempo integral

Benefícios oferecidos por esta vaga

Global health insurance

Flexible work arrangements

Life assurance

Employee assistance program

Resumo da vaga

ICON is a global healthcare intelligence and clinical research organisation committed to delivering faster access to medicines for patients. We seek a Global Senior Regulatory Scientist in Australia to provide high-level regulatory and scientific expertise across global development strategies and submissions.

You will mentor colleagues and lead cross-functional regulatory projects, ensuring robust regulatory positions, high-quality documents, and successful interactions with health authorities.

Qualificações

• Bachelor's degree in a relevant scientific discipline or healthcare-related field.
• Extensive experience in regulatory affairs or regulatory science within pharma, biotech, and CRO environments.
• Strong knowledge of global clinical development regulations (FDA, EMA, ICH) and regional requirements.
• Excellent written and verbal communication abilities with meticulous attention to detail.
• Willingness to travel as required (approximately 10%).

Responsabilidades

• Lead the development of global regulatory strategies for clinical programmes, including plans for key health authority interactions and milestones.
• Author and review complex regulatory documents such as clinical trial applications, briefing books, and major submission components.
• Interpret evolving global regulations, guidelines, and precedents, advising teams on implications for programme design and execution.
• Provide strategic input into clinical development plans, risk management strategies, and labelling considerations.
• Represent regulatory functions in sponsor and health authority meetings with scientifically robust communication.
• Mentor junior regulatory colleagues and contribute to internal best practices and knowledge sharing.

Conhecimentos

Regulatory strategy

Regulatory writing

Cross-functional leadership

Data analysis

Mentoring

Formação

Bachelor's degree in a relevant scientific discipline

Descrição da vaga

ICON is a global healthcare intelligence and clinical research organisation committed to delivering faster access to medicines for patients. We seek a Global Senior Regulatory Scientist in Australia to provide high-level regulatory and scientific expertise across global development strategies and submissions.

You will mentor colleagues and lead cross-functional regulatory projects, ensuring robust regulatory positions, high-quality documents, and successful interactions with health authorities.