Regulatory/Senior Regulatory Scientist

Regulatory/Senior Regulatory Scientist

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.

Completes 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.

Responsibilities

Minimum of 3 years’ relevant regulatory experience
• Read, write and speak fluent English; fluent in host country language
• Travel less than 5%
• Recognize, exemplify and adhere to ICON's values which centre 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
• Ensure 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 ICON’s SOPs/WIs, ICH, GCP and appropriate regulations
• Advanced knowledge of ICON systems applicable to role
• Advanced knowledge of country/region Regulatory Agency (RA), Central Ethics Committee (CEC) and other country-level authority clinical trial requirements, as applicable
• Input to strategic planning of submissions to RA, CEC and other country-level bodies, including proactive identification and mitigation of risks, as applicable
• Direct interaction with RA, CEC and other country-level bodies
• Ensure timely preparation/creation/adaptation/coordination/collation of submission pack/documentation 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
• Manage submissions through lifecycle to approval in line with contractual agreement
• Maintain agreed timelines
• Ensure project team is informed of applicable clinical trial Regulatory submissions and approvals in accordance with 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
• Any other duties deemed necessary to secure the success of ICON’s business

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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, 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.

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