Global Regulatory Lead

pAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. /p pAs 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. /p pThe 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. /p pWorking 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. /p h3What You Will Be Doing /h3 ul liProvide strategic global regulatory leadership for assigned early development programs, ensuring clear regulatory direction, proactive risk management, and alignment across multidisciplinary teams. /li liDevelop and execute innovative global regulatory strategies that support expedited clinical development and critical early development milestones through completion of First-in-Human studies. /li liEmbed patient-focused approaches into regulatory planning and development strategies. /li liServe as a key member of the Early Development Regulatory Team, contributing to team growth, culture, and operational excellence. /li liRepresent Regulatory Affairs within governance committees and development forums, providing timely and actionable regulatory guidance to support business decision-making. /li liPartner closely with asset teams to facilitate seamless transition of programs from early to later stages of development. /li liCollaborate with regulatory leadership to establish and enhance processes, infrastructure, and operational efficiencies. /li liMentor, coach, and develop members of the regulatory organization. /li liBuild and maintain strong relationships with internal stakeholders across Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, Commercial, and Business Development. /li liMonitor, assess, and communicate evolving global regulatory requirements and policy developments that may impact development programs. /li liLead interactions with health authorities and oversee external regulatory vendors to ensure high-quality deliverables and regulatory engagement. /li liProvide hands‑on support for key regulatory submissions and interactions, including Scientific Advice procedures, INDs, CTAs, expedited development pathways, and other regulatory activities. /li liContribute regulatory expertise to business development assessments, due diligence activities, and portfolio strategy discussions, as appropriate. /li /ul h3What You Need /h3 h3Required Qualifications /h3 ul liBachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline. /li liAt least 5-7 years of experience leading global regulatory strategies and teams. /li liDeep knowledge of global regulatory frameworks, including significant experience with major regulatory agencies such as FDA, EMA, and PMDA. /li liDemonstrated experience supporting innovative therapies through early clinical development, including First-in-Human studies. /li liProven expertise in developing and implementing global regulatory strategies that support efficient asset progression and key development decisions. /li liExperience conducting health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways. /li liStrong leadership skills with the ability to influence without authority in a highly matrixed organization. /li liExcellent verbal, written, presentation, and stakeholder management skills. /li liStrong project management, prioritization, and organizational capabilities. /li /ul h3Preferred Qualifications /h3 ul liAdvanced scientific degree (PhD, PharmD, MD, or equivalent). /li liExperience across both early and late-stage drug development. /li liScientific expertise in Immunology and/or related therapeutic areas. /li liKnowledge of diverse therapeutic modalities, including biologics, monoclonal antibodies, peptides, siRNA, and small molecules. /li liExperience integrating biomarker strategies, patient engagement initiatives, and patient‑relevant evidence into development and regulatory plans. /li liExperience supporting business development transactions, portfolio assessments, and regulatory due diligence. /li liDemonstrated interest in leveraging AI‑enabled and digital solutions to enhance regulatory strategy, intelligence gathering, and document development