Regulatory/Senior Regulatory Scientist - UK/Ireland
ICON plc is a leading healthcare intelligence and clinical research organization committed to fostering an inclusive environment that drives innovation and excellence. Join us to help shape the future of clinical development.
Role Overview
Responsible for completing country and/or regional Clinical Trial Regulatory deliverables according to study specifics, ICON policies, procedures, applicable regulations, and ICH-GCP principles, with sound scientific and technical basis, in line with contractual agreements.
Responsibilities
* Ensure regulatory deliverables are performed in accordance with relevant regulations, guidelines, policies, and procedures within contractual timelines and budgets.
* Manage submissions through their lifecycle to approval, maintaining accuracy and completeness in systems like CTMS and eTMF.
* Coordinate internal and external review of submissions and documentation.
* Maintain communication with Regulatory Agencies, Ethics Committees, and other authorities.
* Contribute to strategic planning of regulatory submissions and risk mitigation.
* Support project teams with updates on regulatory statuses and ensure training completion.
* Mentor junior team members and contribute to system and procedure reviews as appropriate.
Qualifications
* Minimum of 3 years’ relevant regulatory experience.
* Fluent in English (reading, writing, speaking).
* Strong knowledge of ICON’s SOPs/WIs, ICH, GCP, and applicable regulations.
* Familiarity with country-specific regulatory requirements and agency interactions.
* Ability to manage multiple submissions and coordinate documentation effectively.
What ICON Offers
Competitive salary and benefits, including various leave entitlements, health insurance, retirement plans, Employee Assistance Program, and flexible optional benefits. We value diversity and are committed to an inclusive, accessible workplace.
Visit our careers site for more information on benefits.
ICON is an equal opportunity employer. We welcome applications from all qualified candidates and provide reasonable accommodations during the application process.
If you’re interested but unsure about meeting all requirements, we encourage you to apply. Current ICON employees can apply here.
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