About this role
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
We are currently seeking a Regulatory Affairs Specialist to join our diverse and dynamic team. As a Regulatory Affairs Specialist at ICON, you will complete country and/or regional Clinical Trial Regulatory deliverables according to study specifics, ICON policies, procedures, applicable regulations and the principles of ICH-GCP with sound scientific/technical principles in line with contractual agreement.
Depending upon experience, become involved, when required, staff training/mentoring and contribute to the review of ICON systems and procedures as appropriate
What you will be doing:
• Input to strategic planning of submissions to RA (DDCM and DEEC), and other country-level bodies, including proactive identification and mitigation of risks, as applicable.
• Direct interaction with regulatory authorities (mainly ANVISA) and other country-level bodies.
• Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation (DDCM and DEEC) according to applicable requirements.
• Arrange internal/external review of submission/documentation according to project requirements.
• Track and file central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable systems ensuring accuracy and completeness of data/documents entered.
• Perform translation management according to project requirements.
• Collaborate with other roles in-country/region to meet ICON’s deliverables.
• Ensure all project-specific training is completed on time, as applicable.
• Adhere to study budget and proactively identifies out of scope activities.
• Support the surveillance, collection, and maintenance of accurate, up-to-date clinical trial global/regional/country and regulatory clinical trial intelligence.
• May mentor junior team members.
• May contribute to the review of ICON systems and procedures as appropriate.
Your profile:
• 2+ years of experience in clinical trial submissions.
• Experience ensuring regulatory deliverables are performed in accordance with all relevant regulations, guidelines, policies and procedures within contractual timelines and budget with sound scientific/technical principles.
• Advanced knowledge of country/region Regulatory Agency (RA) and other country-level authority clinical trial requirements, as applicable.
• Read, write and speak fluent English.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
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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, 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 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
Other facts
About ICON plc
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
What you'll do
- The Regulatory Affairs Specialist will complete country and regional Clinical Trial Regulatory deliverables and interact directly with regulatory authorities. Responsibilities include preparing submission documentation, tracking approval progress, and collaborating with team members to meet deliverables.
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