ICON plc
ICON plc
ICON plc स्वास्थ्य सेवा और फार्मास्युटिकल उद्योगों को सेवाएँ प्रदान करने वाला एक वैश्विक कॉन्ट्रैक्ट रिसर्च संगठन है। इसका कार्य क्लिनिकल, परामर्श और वाणिज्यिक सेवाओं तक फैला है, जो शुरुआती अनुसंधान से लेकर विपणन-पश्चात गतिविधियों तक दवा विकास में सहायता करती हैं। कंपनी विकेंद्रीकृत क्लिनिकल परीक्षण, हृदय सुरक्षा, प्रारंभिक क्लिनिकल प्रयोगशालाएँ, मेडिकल इमेजिंग, नियामक इंटेलिजेंस और वास्तविक-विश्व साक्ष्य जैसी सेवाएँ प्रदान करती है। ICON plc हृदय रोग, ऑन्कोलॉजी, आंतरिक चिकित्सा, सेल और जीन थेरेपी तथा बायोसिमिलर जैसे क्षेत्रों में चिकित्सीय विशेषज्ञता भी उपलब्ध कराती है। डेटा विश्लेषण और रोगी-केंद्रित दृष्टिकोणों को मिलाकर कंपनी क्लिनिकल कार्यक्रमों को आगे बढ़ाने में मदद करती है।

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.

विवरण

  • 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

आवश्यकताएँ

  • 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

लाभ

  • 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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