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For Companies At a Glance
- Tasks: Manage regulatory submissions and ensure compliance with guidelines and timelines.
- Company: ICON plc is a top healthcare intelligence and clinical research organisation focused on innovation.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and a supportive work environment.
- Why this job: Shape the future of clinical development while working in an inclusive and diverse culture.
- Qualifications: 3+ years of regulatory experience and strong knowledge of relevant regulations required.
- Other info: Open to all qualified candidates; apply even if you don't meet every requirement.
The predicted salary is between 36000 - 60000 £ per year.
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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Regulatory/Senior Regulatory Scientist - UK/Ireland employer: ICON
Contact Detail:
ICON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory/Senior Regulatory Scientist - UK/Ireland
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements for clinical trials in the UK and Ireland. Understanding the nuances of local regulations will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the regulatory field, especially those who have experience with ICON or similar organisations. Engaging with industry contacts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in regulatory guidelines, particularly ICH-GCP principles. Being knowledgeable about current developments will show your proactive approach and dedication to the field.
✨Tip Number 4
Prepare to discuss your experience managing submissions and coordinating documentation effectively. Be ready to share specific examples that highlight your organisational skills and ability to meet deadlines.
We think you need these skills to ace Regulatory/Senior Regulatory Scientist - UK/Ireland
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly read the job description for the Regulatory/Senior Regulatory Scientist position. Understand the key responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your regulatory experience, particularly any roles that involved managing submissions or working with regulatory agencies. Use specific examples to demonstrate your expertise in ICH-GCP principles and country-specific regulations.
Showcase Communication Skills: Since the role involves maintaining communication with various stakeholders, highlight your communication skills in your application. Provide examples of how you've effectively communicated with regulatory agencies or coordinated with project teams.
Tailor Your Application: Customise your CV and cover letter to reflect the specific requirements of the job at ICON plc. Mention your familiarity with their SOPs/WIs and how your background aligns with their commitment to innovation and excellence in clinical development.
How to prepare for a job interview at ICON
✨Know Your Regulations
Familiarise yourself with the relevant regulations, guidelines, and policies that govern clinical trials. Being well-versed in ICH-GCP principles and ICON's SOPs will demonstrate your expertise and commitment to compliance during the interview.
✨Showcase Your Experience
Prepare to discuss your previous regulatory experience in detail. Highlight specific projects where you managed submissions or coordinated documentation, as this will illustrate your ability to handle the responsibilities of the role effectively.
✨Communicate Clearly
Effective communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex regulatory topics. This will help convey your understanding and ability to maintain communication with Regulatory Agencies and Ethics Committees.
✨Demonstrate Leadership Skills
As a Senior Regulatory Scientist, mentoring junior team members is part of the job. Be prepared to share examples of how you've supported or guided others in your previous roles, showcasing your leadership and teamwork abilities.
