[Hiring] Global Labeling Lead @ICON plc

Role Description

We are currently seeking a Global Labeling Lead to join our diverse and dynamic team. As a Global Labeling Lead at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

• Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
• Control the consistency of labeling through review of content across the product family.
• Identify areas of potential non-compliance and support investigations as needed.
• Escalate issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS), Reference, or Master labels) into product labeling to ensure compliance with regulations and standard processes.
• Lead and facilitate the global/regional labeling working groups to support the development of core and major regional labeling.
• Provide regulatory expertise and guidance for the development and submission of European labeling components.
• Control the consistency of European and ROW labeling content through alignment with the core documents across product families and with all applicable best practices.
• Generate target product label.
• Generate USPI for new products and drive revisions for marketed products.
• Generate SmPC for new products and drive revisions for marketed products.
• Generate initial CCDS.

Qualifications

• 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.

Benefits

• 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, TELUS Health, 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.