Global Labelling Lead

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.

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.

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.

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.

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