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ICON plc
ICON plc
ConsultingHealthcareLogistics
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.
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Senior Global Regulatory Scientist – ICON plc, Sydney Onsite

Lead global regulatory strategy and submissions for ICON plc’s clinical development programmes in Sydney. Advise on health authority engagement, regulatory planning, and cross-functional programme execution.

AUAustraliaOn-siteFull-timeSeniorEnglish RequiredCompliance

Description

  • Develop global regulatory strategies for clinical programmes, including health authority engagement plans and key milestones
  • Draft and review complex regulatory materials, including clinical trial applications, briefing books, and major submission components
  • Assess changing global regulations, guidance, and precedents to advise on programme design and delivery
  • Shape clinical development plans, risk management approaches, and labelling strategies through regulatory expertise
  • Represent regulatory teams in sponsor and health authority discussions with clear, scientifically grounded communication
  • Support junior regulatory professionals while advancing internal practices, templates, and knowledge-sharing

Requirements

  • Bachelor’s degree in a relevant science or healthcare discipline
  • Extensive regulatory affairs or regulatory science experience in pharmaceutical, biotechnology, or CRO settings
  • Strong understanding of global clinical development regulations, including FDA, EMA, and ICH frameworks, as well as regional requirements
  • Advanced scientific, analytical, and critical-thinking abilities for developing regulatory positions from complex data
  • Highly developed written and verbal communication skills with strong attention to detail
  • Demonstrated experience engaging with health authorities and leading cross-functional regulatory initiatives
  • Availability to travel as needed, approximately 10%
  • Legal authorization to work in the country where the position is located

Benefits

  • Competitive base pay with performance-based incentives
  • Health and wellbeing programmes, including medical, dental, and vision coverage where applicable
  • Retirement and pension programmes
  • Life assurance and disability protection
  • Employee assistance services and wellbeing resources
  • Structured training, learning, and career development opportunities

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