Global Regulatory Lead
ICON plc · Mechelen
Early Development Global Regulatory LeadAt 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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply