Regulatory/Senior Regulatory Scientist - UK/Ireland

ICON; Reading; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading healthcare intelligence firm is seeking a Senior Regulatory Scientist in Reading, UK. The role involves managing regulatory submissions, ensuring compliance with ICH and GCP guidelines, and mentoring junior team members. Candidates should have at least 3 years of relevant experience and be fluent in English. The company offers a competitive salary, health insurance, and various employee benefits in an inclusive workplace.

Benefits

Competitive salary

Health insurance

Retirement plans

Flexible benefits

Qualifications

• 3+ years of relevant regulatory experience.
• Strong knowledge of regulatory guidelines and ICON’s SOPs.
• Ability to coordinate documentation for multiple submissions.

Responsibilities

• Ensure regulatory deliverables meet all relevant regulations and deadlines.
• Manage lifecycle of submissions to approval.
• Maintain communication with regulatory bodies and ethics committees.

Skills

Regulatory submissions management

Fluent English

Knowledge of ICH and GCP

Multitasking

Job description

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.