Regulatory Affairs Specialist

Regulatory affairs Specialist UK/Homebased - with Travel site once per month in the London area

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Position Overview:

Due to the continued growth of our Regulatory affairs teams at ICON I am hiring a Regulatory affairs Specialist fully embedded within a Top 5 Global Pharma that reimagines medicines to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease.

This role will support the publication and transmission of quality regulatory submissions to the UK Health Authority, ensuring compliance to industry and business standards.

What you will be doing:

• Publishing and submission of technically valid eCTD sequences 
• 1^st line contact with Country Regulatory Responsible to agree plan and timelines for finalisation of national submission packages
• Tracking of UK RA publishing workload and priorities
• Initiation of planning activities with global publishing functions and systems (eg. Ops RADAR)
• 1^st line contact with Global Publishing responsible to ensure timely and accurate submission package
• Compilation of eCTD package to “ready for submission” stage
• Maintenance of local eCTD documentation
• Transmission of submission package to UK Health Authority
• Tracking submission package to UK HA acknowledgement
• Resolving technical validation queries

You are:

• An undergraduate degree ideally in science, or health-related field.
• Expert knowledge of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
• Fluency in written and spoken English.

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 organisation. 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 the form below.

https://careers.iconplc.com/reasonable-accommodations

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.