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About the role
- Senior Regulatory Scientist at ICON providing expertise to support global clinical development strategies and submissions. Navigating regulatory landscapes to enable successful program execution.
Responsibilities
- Deliver regulatory submissions in accordance with contractual timelines, budget, and quality standards.
- Apply advanced knowledge of ICON SOPs/WIs, ICH-GCP, and local regulatory requirements.
- Contribute to strategic planning of submissions to Regulatory Authorities (RA), Central Ethics Committees (CEC), and other applicable bodies.
- Prepare, adapt, coordinate, and collate submission documentation per study and country requirements.
- Manage internal and external reviews of regulatory documentation and ensure accuracy of data in systems such as CTMS and eTMF.
- Oversee translation management and submission lifecycle through approval.
- Maintain proactive communication with project teams to ensure timely updates on submission and approval status.
- Collaborate cross-functionally to ensure regulatory deliverables are met.
- Support maintenance of up-to-date clinical trial regulatory intelligence across global and regional levels.
- Mentor junior team members and contribute to the ongoing enhancement of ICON’s regulatory processes.
Requirements
- Educated to degree level in life sciences or related discipline.
- Experienced with a minimum of 3 years’ relevant regulatory experience in clinical research.
- Fluent in English.
- Highly organized with excellent attention to detail and ability to manage multiple priorities.
- A strong communicator with the ability to engage internal teams and external stakeholders effectively.
Benefits
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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