Global Regulatory Lead - Early Development Strategy Leader

ICON Strategic Solutions; Belgique; On-site; EUR 120,000 - 180,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme (

Life assurance

Job summary

ICON Strategic Solutions is seeking a Global Regulatory Lead, Early Development (ED-GRL) to drive regulatory strategy across preclinical through early clinical development. You will partner with cross-functional teams, advise on agency interactions, and lead submissions for First-in-Human studies, aiming to accelerate programs while ensuring compliance.

In this senior role, you will mentor the Regulatory Affairs group, shape global regulatory plans, and represent the function in governance

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 FDA, EMA, and PMDA.
• Experience supporting innovative therapies through early clinical development, including First-in-Human studies.
• Proven expertise in developing and implementing global regulatory strategies that support asset progression.
• Experience conducting health authority interactions, Scientific Advice meetings, IND/CTA submissions, and expedited regulatory pathways.
• Strong leadership skills with the ability to influence in a matrixed organization.
• Excellent verbal, written, presentation, and stakeholder management skills.
• Strong project management and organizational capabilities.

Responsibilities

• Provide strategic global regulatory leadership for assigned early development programs with clear direction and risk management.
• Develop and execute global regulatory strategies to support expedited development milestones through 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 and contribute to growth and operational excellence.
• Represent Regulatory Affairs in governance committees and development forums with timely guidance for business decisions.
• Partner with asset teams to enable smooth transition from early to later development stages.
• Collaborate with regulatory leadership to enhance processes and infrastructure.
• Mentor, coach, and develop members of the regulatory organization.
• Build relationships with Clinical Development, Translational Medicine, CMC, Biometrics, Medical Affairs, and Commercial teams.
• Monitor evolving global regulatory requirements and policy developments relevant to programs.
• Lead health authority interactions and oversee external vendors for high-quality deliverables.
• Provide hands-on support for submissions and interactions, including Scientific Advice, INDs, CTAs, and expedited pathways.
• Contribute regulatory expertise to BD assessments and due diligence.

Skills

Leadership

Regulatory strategy

Stakeholder management

Project management

Communication

Education

Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline

Advanced scientific degree (PhD, PharmD, MD, or equivalent)

Job description

ICON Strategic Solutions is seeking a Global Regulatory Lead, Early Development (ED-GRL) to drive regulatory strategy across preclinical through early clinical development. You will partner with cross-functional teams, advise on agency interactions, and lead submissions for First-in-Human studies, aiming to accelerate programs while ensuring compliance.

In this senior role, you will mentor the Regulatory Affairs group, shape global regulatory plans, and represent the function in governance