Regulatory Submissions Manager

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🕒 2 days ago

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA • Provide regulatory guidance and efforts to internal teams • Participate in agency interactions and regulatory submissions • Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines • Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

🎯 Requirements

• Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotech industry • Prior experience with various regulatory submissions, including CTA/IND/MAA • Ability to lead internal teams and carry out regulatory activities independently • Strong understanding of global regulatory requirements and guidelines

🏖️ 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