Global Labelling Lead

Global Labelling Manager

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 Global labeling lead, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

This is a 12-month fixed term contract, fully homebased.

What You Will Do:

You will oversee regulatory affairs operations, balancing quality, timelines, and stakeholder expectations.

Key responsibilities include:

• Develop and implement regulatory labeling strategies for drug development projects.
• Ensure compliance with global regulatory requirements and standards related to labeling.
• Manage the creation, review, and approval of labeling documents, including package inserts, patient leaflets, and labels.
• Coordinate labeling activities with cross-functional teams, including regulatory affairs, clinical development, and quality assurance.
• Provide regulatory guidance and assist to internal teams and external clients on labeling-related issues.

Your Profile:

You will have a strong background in regulatory affairs, with proven management experience and a commitment to quality delivery.

Required qualifications and experience:

• Bachelor's degree in a scientific discipline or related field.
• Minimum of 8 years of experience in regulatory affairs or labeling within the pharmaceutical or biotechnology industry.
• Strong understanding of global regulatory requirements and guidelines related to labeling.
• Excellent communication and interpersonal skills.
• Ability to work independently and collaboratively in a fast-paced environment.

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.

Are you a current ICON Employee? Please click here to apply