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- Tasks: Lead regulatory operations and ensure compliance in clinical trials.
- Company: Join ICON, a leader in healthcare intelligence and clinical research.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and work-life balance.
- Why this job: Shape the future of clinical development in an inclusive and innovative environment.
- Qualifications: Bachelor's degree required; 8+ years in regulatory affairs preferred.
- Other info: Diversity and inclusion are core values at ICON; all applicants are encouraged to apply.
The predicted salary is between 43200 - 72000 £ per year.
Director, Regulatory Operations
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.
We are currently seeking a Director, Regulatory Operations to join our diverse and dynamic team. As a Director, Regulatory Operations at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.
What you will be doing:
- Lead and oversee regulatory operations activities to ensure compliance with applicable regulations and guidelines.
- Develop strategies for regulatory submissions and approvals, including INDs, NDAs, BLAs, and marketing authorization applications.
- Collaborate with cross-functional teams to provide regulatory guidance and support throughout the drug development process.
- Manage regulatory submissions and timelines, ensuring accuracy and completeness of documentation.
- Stay abreast of evolving regulatory requirements and trends to inform decision-making and strategy development.
Your profile:
- Bachelor’s degree in a scientific or related field; advanced degree preferred.
- 8+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Strong understanding of global regulatory requirements and guidelines.
- Proven track record of successful regulatory submissions and approvals.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams and with regulatory agencies.
- Proven leadership experience.
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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers, and our communities. We’re proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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.
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Director, Regulatory Operations employer: ICON plc
Contact Detail:
ICON plc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Regulatory Operations
✨Tip Number 1
Familiarize yourself with the latest global regulatory requirements and guidelines. This knowledge will not only help you in interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs space, especially those who have experience in pharmaceutical or biotechnology industries. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of successful regulatory submissions you've managed. Highlighting your proven track record will showcase your expertise and leadership capabilities during the interview process.
✨Tip Number 4
Research ICON plc's recent projects and initiatives in clinical development. Being knowledgeable about the company's work will allow you to tailor your responses and show how you can contribute to their mission.
We think you need these skills to ace Director, Regulatory Operations
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Director, Regulatory Operations position. Understand the key responsibilities and required qualifications to tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 8+ years of experience in regulatory affairs, particularly any successful regulatory submissions and approvals you've managed. Use specific examples to demonstrate your expertise.
Showcase Leadership Skills: Since the role requires proven leadership experience, make sure to include instances where you led teams or projects. Highlight your ability to collaborate with cross-functional teams and provide regulatory guidance.
Tailor Your Application: Customize your cover letter to reflect your understanding of ICON's values, especially their commitment to diversity and inclusion. Mention how your background aligns with their mission and how you can contribute to their goals.
How to prepare for a job interview at ICON plc
✨Understand Regulatory Frameworks
Make sure you have a solid grasp of the global regulatory requirements and guidelines relevant to the pharmaceutical and biotechnology industries. Be prepared to discuss how these frameworks influence your approach to regulatory submissions and approvals.
✨Showcase Leadership Experience
Highlight your proven leadership experience in regulatory affairs. Share specific examples of how you've led teams or projects, particularly in managing regulatory submissions and ensuring compliance with regulations.
✨Demonstrate Cross-Functional Collaboration
Prepare to discuss your experience collaborating with cross-functional teams. Provide examples of how you've worked with different departments to provide regulatory guidance and support throughout the drug development process.
✨Stay Updated on Industry Trends
Be ready to talk about recent changes in regulatory requirements and trends. Show that you are proactive in staying informed and how this knowledge has influenced your decision-making and strategy development in past roles.
