Senior Regulatory Scientist

ICON plc; Reading; On-site; GBP 50,000 - 80,000; Full time

Job summary

ICON plc, a leader in healthcare intelligence and clinical research, is seeking a Senior Regulatory Scientist based in the UK. This role involves coordinating clinical trial regulatory deliverables, ensuring compliance with guidelines, and providing mentorship within the team. ICON is dedicated to fostering an inclusive workplace and offers competitive benefits, emphasizing work-life balance and professional growth.

Benefits

Various annual leave entitlements

A range of health insurance offerings

Competitive retirement planning offerings

Global Employee Assistance Programme

Flexible optional benefits

Qualifications

• Minimum of 3 years of relevant regulatory experience.
• Experience in clinical trial regulatory deliverables.
• Strong understanding of ICH-GCP guidelines.

Responsibilities

• Ensure regulatory deliverables are completed according to guidelines.
• Coordinate submission documentation and manage submission lifecycle.
• Collaborate with clients and regulatory bodies for approvals.

Skills

Regulatory compliance

Fluent English

Process improvement

Education

Relevant degree in life sciences or related field

Job description

Senior Regulatory Scientist - UK based

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
• 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
  
  

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
• 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, 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