Regulatory Affairs Specialist in Reading

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Regulatory Affairs Specialist at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

What You Will Do:

• Your role will involve delivering regulatory affairs work to a high standard, working closely with your team and stakeholders.
• Key responsibilities include:
• Undertaking variable duties based on project requirements, primarily within Pharmaceutical, Biotechnology, or Biologics Regulatory Affairs, with potential involvement in related areas.
• Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation.
• Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions.
• Providing input to the Regulatory Intelligence function and participating in readability testing.
• Reviewing IMPD/IB Core Docs and labeling for clinical trials.
• Collaborating with Regulatory Submissions team or cross‑functional teams based on project size and nature.
• Facilitating business development activities as needed.

Your Profile:

You will bring relevant regulatory affairs experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in a relevant scientific discipline or healthcare‑related field.
• Familiarity with label review, translation requirements, and regulatory intelligence activities.
• Strong attention to detail and excellent communication skills.

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.

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.