Global Labelling Lead

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🔥 6 minutes ago

🌐 United Kingdom, India, +4 more countries – Remote

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⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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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

• Oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations • Develop and implement regulatory labeling strategies for drug development projects • Ensure compliance with global regulatory requirements and standards related to labeling • Manage the creation, review, and approval of labeling documents, including package inserts, patient leaflets, and labels • Coordinate labeling activities with cross-functional teams, including regulatory affairs, clinical development, and quality assurance • Provide regulatory guidance and assist internal teams and external clients on labeling-related issues

🎯 Requirements

• Bachelor's degree in a scientific discipline or related field • Minimum of 8 years of experience in regulatory affairs or labeling within the pharmaceutical or biotechnology industry • Strong understanding of global regulatory requirements and guidelines related to labeling • Excellent communication and interpersonal 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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