Regulatory Affairs Manager

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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

• Oversee regulatory affairs workstreams, ensuring deliverables meet quality and timeline expectations • Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, ensuring full compliance with local and global regulatory requirements • Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines • Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations • Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure timely submissions, approvals, and updates for ongoing clinical studies • Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs • Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in assigned region, and proactively communicate implications to project teams • Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation • Contribute to cross-functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across regions • Provide mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and maintenance

🎯 Requirements

• Bachelor's degree in a relevant scientific discipline or healthcare-related field • Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology 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 • Employment with ICON is contingent upon having the 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