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- Tasks: Lead regulatory submissions and ensure compliance for clinical trials.
- Company: Join ICON plc, a leader in healthcare intelligence and clinical research.
- Benefits: Enjoy competitive salary, health insurance, flexible benefits, and work-life balance.
- Other info: Diverse culture with opportunities for career growth and mentorship.
- Why this job: Make a real impact in drug development and shape the future of clinical research.
- Qualifications: Bachelor's degree and 6+ years in regulatory affairs required.
The predicted salary is between 60000 - 80000 £ 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 Global submission manager at ICON, you will contribute to drug development as part of the Regulatory Affairs team. This position serves as the regional regulatory representative within study teams, responsible for obtaining and maintaining clinical trial authorizations for compounds in development or marketed products under investigation for new indications.
What You Will Do:
- You will oversee regulatory affairs workstreams, ensuring deliverables meet quality and timeline expectations.
- Lead the preparation, submission, and maintenance of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) applications, ensuring full compliance with local and global regulatory requirements.
- Develop and implement regional clinical trial regulatory strategies aligned with global development objectives and timelines.
- Provide strategic input to clinical study teams and Global/Regional Regulatory Leads (GRL/RRL) to ensure trial design, documentation, and execution meet regional regulatory expectations.
- Collaborate closely with the Clinical Trial Unit RA, Early Development, Clinical Operations, and Global Regulatory Affairs to ensure timely submissions, approvals, and updates for ongoing clinical studies.
- Prepare, review, and ensure the quality, scientific integrity, and regulatory compliance of technical and administrative documentation supporting CTAs/INDs.
- Monitor and interpret changes in clinical trial regulations, guidelines, and regulatory trends in assigned region, and proactively communicate implications to project teams.
- Support regulatory inspections, audits, and compliance activities related to clinical trial conduct and documentation.
- Contribute to cross‑functional initiatives to enhance regulatory efficiency, harmonize submission processes, and maintain best practices across regions.
- Provide mentorship and regulatory guidance to internal stakeholders on regional regulatory processes and expectations for clinical trial approvals and maintenance.
- As agreed with regional or global regulatory management, may provide support for clinical trial submissions and maintenance activities in other countries within the assigned region.
Your Profile:
You will have solid global regulatory affairs experience, with the ability to manage competing priorities and develop your team.
Required qualifications and experience:
- Bachelor's degree in a relevant scientific discipline or healthcare-related field.
- Minimum of 6 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Prior experience with various regulatory submissions, including CTA/IND/MAA.
- Ability to lead internal teams and carry out regulatory activities independently.
- Strong understanding of global regulatory requirements and guidelines.
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.
- 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.
Global Regulatory Submission Manager employer: ICON
Contact Detail:
ICON Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Submission Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs field on LinkedIn or at industry events. A friendly chat can open doors and lead to job opportunities that aren’t even advertised.
✨Tip Number 2
Prepare for interviews by researching ICON and its regulatory processes. Show us you’re not just another candidate; demonstrate your understanding of our mission and how you can contribute to shaping the future of clinical development.
✨Tip Number 3
Practice your pitch! Be ready to explain your experience with CTAs and INDs clearly and confidently. We want to hear how your background aligns with the role and how you can help us meet our regulatory goals.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re genuinely interested in joining our team at ICON.
We think you need these skills to ace Global Regulatory Submission Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Global Regulatory Submission Manager role. Highlight your relevant experience in regulatory affairs, especially with CTAs and INDs, and don’t forget to showcase your ability to manage competing priorities.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background aligns with ICON's mission. Be sure to mention any specific achievements that demonstrate your expertise.
Showcase Your Team Leadership Skills: Since this role involves leading internal teams, make sure to highlight your leadership experience. Share examples of how you've successfully guided teams through regulatory processes or managed projects to meet tight deadlines.
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of success. It’s the easiest way for us to keep track of your application and ensure it gets the attention it deserves!
How to prepare for a job interview at ICON
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of global regulatory requirements and guidelines. Familiarise yourself with the specifics of Clinical Trial Applications (CTAs) and Investigational New Drug (IND) submissions, as these will likely come up during your interview.
✨Showcase Your Leadership Skills
As a Global Regulatory Submission Manager, you'll need to lead teams effectively. Prepare examples of how you've successfully managed competing priorities and guided teams in previous roles. This will demonstrate your ability to take charge and deliver results.
✨Be Ready for Scenario Questions
Expect questions that put you in hypothetical situations related to regulatory challenges. Think about how you would handle changes in regulations or unexpected issues during a submission process. Practising these scenarios can help you articulate your thought process clearly.
✨Highlight Your Collaborative Spirit
Collaboration is key in this role, so be prepared to discuss how you've worked with cross-functional teams in the past. Share specific examples of how you’ve contributed to enhancing regulatory efficiency and harmonising submission processes across different regions.