Global Regulatory Lead

pGlobal Regulatory Lead /p 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 lipProvide strategic global regulatory leadership for assigned early development programs, ensuring clear regulatory direction, proactive risk management, and alignment across multidisciplinary teams. /p /li lipDevelop and execute innovative global regulatory strategies that support expedited clinical development and critical early development milestones through completion of First-in-Human studies. /p /li lipEmbed patient-focused approaches into regulatory planning and development strategies. /p /li lipServe as a key member of the Early Development Regulatory Team, contributing to team growth, culture, and operational excellence. /p /li lipRepresent Regulatory Affairs within governance committees and development forums, providing timely and actionable regulatory guidance to support business decision-making. /p /li lipPartner closely with asset teams to facilitate seamless transition of programs from early to later stages of development. /p /li lipCollaborate with regulatory leadership to establish and enhance processes, infrastructure, and operational efficiencies. /p /li lipMentor, coach, and develop members of the regulatory organization. /p /li lipBuild and maintain strong relationships with internal stakeholders across Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, Commercial, and Business Development. /p /li lipMonitor, assess, and communicate evolving global regulatory requirements and policy developments that may impact development programs. /p /li lipLead interactions with health authorities and oversee external regulatory vendors to ensure high-quality deliverables and regulatory engagement. /p /li lipProvide hands-on support for key regulatory submissions and interactions, including Scientific Advice procedures, INDs, CTAs, expedited development pathways, and other regulatory activities. /p /li lipContribute regulatory expertise to business development assessments, due diligence activities, and portfolio strategy discussions, as appropriate. /p /li /ul h3What You Need /h3 h3Required Qualifications /h3 ul lipBachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline. /p /li lipAt least 5-7 years of experience leading global regulatory strategies and teams. /p /li lipDeep knowledge of global regulatory frameworks, including significant experience with major regulatory agencies such as FDA, EMA, and PMDA. /p /li lipDemonstrated experience supporting innovative therapies through early clinical development, including First-in-Human studies. /p /li lipProven expertise in developing and implementing global regulatory strategies that support efficient asset progression and key development decisions. /p /li lipExperience conducting health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways. /p /li lipStrong leadership skills with the ability to influence without authority in a highly matrixed organization. /p /li lipExcellent verbal, written, presentation, and stakeholder management skills. /p /li lipStrong project management, prioritization, and organizational capabilities. /p /li /ul h3Preferred Qualifications /h3 ul lipAdvanced scientific degree (PhD, PharmD, MD, or equivalent). /p /li lipExperience across both early and late-stage drug development. /p /li lipScientific expertise in Immunology and/or related therapeutic areas. /p /li lipKnowledge of diverse therapeutic modalities, including biologics, monoclonal antibodies, peptides, siRNA, and small molecules. /p /li lipExperience integrating biomarker strategies, patient engagement initiatives, and patient-relevant evidence into development and regulatory plans. /p /li lipExperience supporting business development transactions, portfolio assessments, and regulatory due diligence. /p /li lipDemonstra