Regulatory Affairs Specialist

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Delivering regulatory affairs work to a high standard, collaborating closely with your team and stakeholders • Undertaking variable duties based on project requirements, primarily within Pharmaceutical, Biotechnology, or Biologics Regulatory Affairs • Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents • Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions • Providing input to the Regulatory Intelligence function • Reviewing IMPD/IB Core Docs and labeling for clinical trials • Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature • Facilitating business development activities as needed

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Familiarity with label review, translation requirements, and regulatory intelligence activities • Strong attention to detail and excellent communication skills

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways