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- Tasks: Lead regulatory deliverables for clinical trials, ensuring compliance and quality.
- Company: Join ICON plc, a top healthcare intelligence and clinical research organisation committed to innovation.
- Benefits: Enjoy competitive salary, flexible work options, health insurance, and wellness programmes.
- Why this job: Be part of a diverse team shaping the future of clinical development with impactful work.
- Qualifications: Minimum 3 years regulatory experience; fluent in English; strong communication skills required.
- Other info: Remote work available; inclusive culture prioritising diversity and employee well-being.
The predicted salary is between 36000 - 60000 £ per year.
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.
As a Senior Regulatory Scientist, you will be working mostly with the ICON Clinical Trial Units in the Netherlands and Hungary. You will be responsible for completion of country 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, you may also be involved with staff training/mentoring and contribution to the review of ICON systems and procedures may be required.
- Minimum of 3 years’ relevant regulatory experience
- Read, write and speak fluent English
- Travel less than 5%
- Recognize, exemplify and adhere to ICON's values which centre around our commitment to People, Clients and Performance
- 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
- 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
- Direct interaction with clients
- 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
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
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.
Senior Regulatory Scientist employer: ICON plc
Contact Detail:
ICON plc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Regulatory Scientist
✨Tip Number 1
Familiarise yourself with the latest regulations and guidelines in clinical trials, especially those relevant to the countries you'll be working with. This knowledge will not only boost your confidence but also demonstrate your commitment to staying updated in the field.
✨Tip Number 2
Network with professionals in the regulatory science community, particularly those who have experience with ICON or similar organisations. Engaging in discussions can provide insights into the company culture and expectations, which can be invaluable during interviews.
✨Tip Number 3
Prepare to discuss specific examples from your past experience that showcase your ability to manage regulatory submissions and interact with regulatory authorities. Highlighting these experiences can set you apart as a candidate who understands the role's demands.
✨Tip Number 4
Showcase your soft skills, such as communication and teamwork, during any interactions with the hiring team. As a Senior Regulatory Scientist, collaboration is key, so demonstrating your ability to work well with others can make a strong impression.
We think you need these skills to ace Senior Regulatory Scientist
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Scientist position. Familiarise yourself with ICON's values and how they align with your own experience and skills.
Tailor Your CV: Customise your CV to highlight relevant regulatory experience, particularly in clinical trials. Emphasise your fluency in English and any specific achievements that demonstrate your ability to meet regulatory deliverables.
Craft a Compelling Cover Letter: Write a cover letter that not only outlines your qualifications but also showcases your understanding of ICON's mission and culture. Mention how your background aligns with their commitment to innovation and excellence in clinical development.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory roles.
How to prepare for a job interview at ICON plc
✨Understand Regulatory Frameworks
Familiarise yourself with the relevant regulations and guidelines, such as ICH-GCP. Being able to discuss these frameworks confidently will demonstrate your expertise and understanding of the role.
✨Showcase Your Experience
Prepare specific examples from your past regulatory experience that highlight your ability to manage submissions and interact with regulatory authorities. This will help illustrate your qualifications for the Senior Regulatory Scientist position.
✨Emphasise Team Collaboration
Discuss your experience working in teams, especially in cross-functional settings. Highlight how you’ve collaborated with other roles to meet project deliverables, as teamwork is crucial in this role.
✨Prepare Questions for the Interviewers
Have thoughtful questions ready about ICON's culture, values, and expectations for the role. This shows your genuine interest in the company and helps you assess if it’s the right fit for you.
