Regulatory CMC (Operations) Coordinator

Regulatory CMC (Operations) Coordinator

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 include:

• 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.

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.

Key competencies:

• Organization and Planning
• Attention to Detail
• Data Accuracy
• Collaboration and Teamwork
• Regulatory Compliance Awareness
• Problem Solving
• Continuous Improvement

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.