Global Regulatory Lead
ICON
ICON seeks a senior regulatory leader to provide strategic guidance on early-stage drug development programs, from preclinical through First-in-Human studies. The role requires deep expertise in global regulatory frameworks and health authority interactions, with responsibility for mentoring teams and driving patient-focused development strategies across innovative therapeutics.
Responsibilities
- Provide strategic regulatory leadership and oversight for assigned early-stage development programs
- Develop and execute global regulatory strategies supporting expedited clinical development and FIH milestones
- Lead health authority interactions and oversee external regulatory vendors for high-quality submissions
- Mentor and develop regulatory team members; represent Regulatory Affairs in governance committees
- Collaborate cross-functionally to facilitate program transition from early to later-stage development
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related scientific discipline
- 5–7 years leading global regulatory strategies and cross-functional teams
- Deep knowledge of FDA, EMA, PMDA, and other major regulatory agencies
- Demonstrated experience supporting innovative therapies through early clinical development
- Expertise in health authority interactions, Scientific Advice, IND/CTA submissions, expedited pathways
- Strong leadership and stakeholder management skills in matrixed organizations
- Excellent written, verbal, and presentation capabilities
Compensation: Competitive base salary and performance-related incentives
L'offre d'emploi a été publiée il y a 7 jours
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