ICON plc este o organizație globală de cercetare în regim contractual, care deservește industriile din domeniul sănătății și farmaceutic. Activitatea sa cuprinde servicii clinice, de consultanță și comerciale care sprijină dezvoltarea medicamentelor, de la cercetarea timpurie până la activitățile post-comercializare. Compania oferă soluții precum studii clinice descentralizate, evaluarea siguranței cardiace, laboratoare clinice pentru etapele timpurii, imagistică medicală, informații de reglementare și dovezi din lumea reală. ICON plc dispune, de asemenea, de expertiză terapeutică în domenii precum bolile cardiovasculare, oncologia, medicina internă, terapiile celulare și genice și medicamentele biosimilare, combinând analiza datelor cu o abordare axată pe pacienți pentru a contribui la avansarea programelor clinice.
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.
Descriere
- 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
Cerințe
- 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
Beneficii
- 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