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 levera