Associate, Global Labeling - Home-Based (US)

As a Regulatory Affiars Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing: 

• Labeling Coordination: Oversee pre- and post-approval labeling activities, ensuring timely updates and compliance with global regulatory requirements.
• Project Management: Develop and maintain a project calendar to track key labeling milestones and deadlines.
• Artwork Coordination: Complete brief forms for artwork creation and revisions; manage artwork implementation and quality control (QC).
• Content Review & Quality Assurance: Conduct content audits and proofreading to ensure accuracy, consistency, and adherence to regulatory requirements.
• Submission Preparation: Prepare final source submission documents for regulatory authorities, including the U.S., EU, and Rest of World markets.
• Regulatory Compliance & Formatting: Execute quality checks and review documents for proper formatting, consistency, and compliance with regulatory guidelines.
• Approval & Tracking: Coordinate and track job routing to facilitate review, receive comments, and obtain final approvals.
• Translation Coordination: Manage translation projects to ensure accurate and timely delivery of localized labeling content.

You Are: 

• Bachelor’s degree in Science or a related field required.
• Minimum of 3 years of relevant experience in pharmaceutical labeling, regulatory affairs, or a related area.
• Strong organizational and project management skills, with the ability to handle multiple tasks and meet tight deadlines.
• Excellent attention to detail and ability to perform thorough content audits and quality checks.
• Proficiency in document management systems and regulatory submission processes.
• Strong communication skills, with the ability to collaborate cross-functionally with regulatory, artwork, and quality teams.

Why Join ICON?

• Work in a dynamic and collaborative environment.
• Gain valuable experience in global regulatory labeling.
• Contribute to ensuring patient safety and compliance in the pharmaceutical industry.

If you are a meticulous professional with a passion for regulatory compliance and project coordination, we encourage you to apply!

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 maximise savings and plan with confidence for the years ahead 
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits 

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. 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 through this form.