ICON plc
Regulatory CMC Coordinator
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Regulatory Coordinator
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
As a Regulatory CMC (Operations) Coordinator at ICON, you will play a key role in supporting the preparation, coordination, and maintenance of Chemistry, Manufacturing and Controls (CMC) documentation for global and local regulatory submissions. Working closely with Regulatory CMC Leads, Regulatory Operations, Quality, and external partners, you will help ensure submission content is accurate, compliant, inspection-ready, and delivered in accordance with internal processes and regulatory requirements.
What You Will Do
In this role, you will provide operational and administrative support across regulatory CMC activities, ensuring the effective coordination of submission documentation, regulatory records, and data management.
Key Responsibilities
- Support the compilation, maintenance, and quality control of CMC regulatory submission documentation, including IMPDs, Module 2.3 and Module 3 content, and Clinical Trial Application (CTA) submissions.
- Prepare, track, and maintain CMC submission plans, manufacturing data, response documents, forms, cover letters, and supporting submission materials within regulatory systems.
- Ensure regulatory documents are maintained in an electronic submission-ready format and support the preparation of submission packages and associated documentation.
- Create and maintain regulatory records, master and country-specific IMPD binders, GMP certificates, Manufacturing Import Authorizations (MIAs), and related compliance documentation.
- Support the review and reconciliation of regulatory data, dossier information, submission trackers, and metadata to ensure accuracy, consistency, and completeness across systems.
- Coordinate with Regulatory CMC Leads, Regulatory Operations, and cross-functional stakeholders to facilitate timely workflow reviews, approvals, and regulatory updates.
- Assist with regulatory information management activities within systems such as RIM platforms, supporting compliance with internal processes and regulatory requirements.
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Your Profile
To succeed in this role, you will bring strong organizational skills, attention to detail, and an interest in regulatory affairs, CMC submissions, and regulatory operations.
Required qualifications and experience
- Bachelor's degree in Life Sciences or a related scientific discipline.
- Experience supporting regulatory submissions, Clinical Trial Applications (CTAs), CMC activities, or regulatory operations within the pharmaceutical, biotechnology, or CRO industry.
- Knowledge of regulatory documentation, including IMPDs, GMP documentation, and electronic submission processes.
- Experience working with electronic document management or regulatory information management systems such as Veeva RIM or similar platforms.
- Strong organizational, communication, and data management skills, with the ability to manage multiple activities while maintaining a high level of accuracy.
Preferred experience
- Knowledge of eCTD requirements, document publishing standards, or electronic submission environments.
- Experience working with regulatory databases, submission tracking tools, and regulatory information management systems.
- Comfortable working in AI-enabled environments and leveraging technology to improve operational efficiency.
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Key competencies
- Organization and Planning
- Attention to Detail
- Data Accuracy
- Collaboration and Teamwork
- Regulatory Compliance Awareness
- Problem Solving
- Continuous Improvement
Employment with ICON
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply.
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