Senior Global Regulatory Affairs Specialist

🔥 14 hours ago

🌐 United Kingdom, Spain, +3 more countries – Remote

infoinfo

⏰ Full Time

🟠 Senior

🚔 Compliance

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Logo of ICON plc

ICON plc

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

• Develop global regulatory strategies for the successful submission and approval of clinical trial applications and marketing authorizations • Provide regulatory guidance and support to cross-functional teams throughout the drug development process • Ensure compliance with global regulatory requirements and standards • Manage regulatory submissions and interactions with health authorities • Participate in regulatory intelligence activities to stay updated on changes in regulations and guidelines • Take ownership of regulatory affairs deliverables and apply expertise to complex challenges

🎯 Requirements

• Bachelor's degree in a scientific discipline or related field • Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry • Strong understanding of global regulatory requirements and guidelines • Excellent communication and social skills • Ability to work independently and collaboratively in a fast-paced environment • Legal right to work in the country where the role is based

🏖️ 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

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