About this role
Global Regulatory Lead
Location: Mechelen
Reference: JR162620
Vacancy area: ICON Strategic Solutions (FSP)
Categories: Drug / Device Regulatory Affairs
Remote: Remote
About the role
Global Regulatory Lead
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
The Global Regulatory Lead, Early Development (ED-GRL) is a senior leader within ICON's Early Development Regulatory Team (EDRT), providing strategic regulatory leadership across the development lifecycle of innovative therapeutics. This role serves as a key business partner to development teams, guiding global regulatory strategy from preclinical and pre-nomination activities through First-in-Human (FIH) studies and early clinical development.
Working collaboratively with cross-functional stakeholders, the ED-GRL will drive patient-focused regulatory strategies, support accelerated development pathways, lead agency interactions, and ensure programs are positioned for successful transition into later-stage development.
What You Will Be Doing
- Provide strategic global regulatory leadership for assigned early development programs, ensuring clear regulatory direction, proactive risk management, and alignment across multidisciplinary teams.
- Develop and execute innovative global regulatory strategies that support expedited clinical development and critical early development milestones through completion of First-in-Human studies.
- Embed patient-focused approaches into regulatory planning and development strategies.
- Serve as a key member of the Early Development Regulatory Team, contributing to team growth, culture, and operational excellence.
- Represent Regulatory Affairs within governance committees and development forums, providing timely and actionable regulatory guidance to support business decision-making.
- Partner closely with asset teams to facilitate seamless transition of programs from early to later stages of development.
- Collaborate with regulatory leadership to establish and enhance processes, infrastructure, and operational efficiencies.
- Mentor, coach, and develop members of the regulatory organization.
- Build and maintain strong relationships with internal stakeholders across Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, Commercial, and Business Development.
- Monitor, assess, and communicate evolving global regulatory requirements and policy developments that may impact development programs.
- Lead interactions with health authorities and oversee external regulatory vendors to ensure high-quality deliverables and regulatory engagement.
- Provide hands-on support for key regulatory submissions and interactions, including Scientific Advice procedures, INDs, CTAs, expedited development pathways, and other regulatory activities.
- Contribute regulatory expertise to business development assessments, due diligence activities, and portfolio strategy discussions, as appropriate.
What You Need
Required Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
- At least 5-7 years of experience leading global regulatory strategies and teams.
- Deep knowledge of global regulatory frameworks, including significant experience with major regulatory agencies such as FDA, EMA, and PMDA.
- Demonstrated experience supporting innovative therapies through early clinical development, including First-in-Human studies.
- Proven expertise in developing and implementing global regulatory strategies that support efficient asset progression and key development decisions.
- Experience conducting health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways.
- Strong leadership skills with the ability to influence without authority in a highly matrixed organization.
- Excellent verbal, written, presentation, and stakeholder management skills.
- Strong project management, prioritization, and organizational capabilities.
Preferred Qualifications
- Advanced scientific degree (PhD, PharmD, MD, or equivalent).
- Experience across both early and late-stage drug development.
- Scientific expertise in Immunology and/or related therapeutic areas.
- Knowledge of diverse therapeutic modalities, including biologics, monoclonal antibodies, peptides, siRNA, and small molecules.
- Experience integrating biomarker strategies, patient engagement initiatives, and patient-relevant evidence into development and regulatory plans.
- Experience supporting business development transactions, portfolio assessments, and regulatory due diligence.
- Demonstrated interest in leveraging AI-enabled and digital solutions to enhance regulatory strategy, intelligence gathering, and document development.
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
Share:
Location Mechelen
Reference JR162620
Business Area ICON Strategic Solutions (FSP)
Categories Drug / Device Regulatory Affairs
Remote Remote
Not Ready to Apply?
Join our Talent Community for future alerts.
Sign up
Explore more about ICON
About ICON
Explore
Global Office Locator
Explore
Benefits & Rewards
Explore
Inclusion & Belonging
Explore
Career Pathways
Explore
Environmental, Social & Governance
Explore