Senior Global Regulatory Lead, Early Development

ICON Clinical Research; Belgique; Remote; EUR 120,000 - 170,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Retirement planning options

Employee assistance programme

Job summary

ICON Strategic Solutions is seeking a Global Regulatory Lead in Belgium to drive strategic regulatory leadership across early development. You will partner with cross-functional teams, guide global regulatory strategy from preclinical to FIH, and ensure programs are positioned for successful progression.

The role requires leading global regulatory strategies, extensive agency interactions, and a focus on accelerated development timelines, with mentorship and governance responsibilities across

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field.
• 5–7 years leading global regulatory strategies and teams.
• Deep knowledge of FDA, EMA, PMDA and global frameworks.
• Experience supporting therapies through early development (FIH).
• Proven ability to drive efficient asset progression and decisions.
• Experience with health authority interactions and expedited pathways.

Responsibilities

• Provide strategic global regulatory leadership for early development programs.
• Develop/execute global regulatory strategies supporting expedited development.
• Embed patient-focused regulatory planning in development strategies.
• Mentor members of the regulatory organization and lead governance discussions.
• Collaborate with asset teams to transition programs from early to later stages.
• Lead regulatory submissions, Scientific Advice, INDs/CTAs, and engagement with agencies.

Skills

Regulatory leadership

Global strategy

Health authority interactions

Cross-functional collaboration

Team mentorship

Project management

Education

Bachelor's degree in Life Sciences

Advanced degree preferred (PhD/MD/PharmD)

Tools

IND/CTA submissions

Scientific Advice knowledge

FDA/EMA/PMDA frameworks

Job description

ICON Strategic Solutions is seeking a Global Regulatory Lead in Belgium to drive strategic regulatory leadership across early development. You will partner with cross-functional teams, guide global regulatory strategy from preclinical to FIH, and ensure programs are positioned for successful progression.

The role requires leading global regulatory strategies, extensive agency interactions, and a focus on accelerated development timelines, with mentorship and governance responsibilities across