Description
As a Global Regulatory Lead at ICON Strategic Solutions, you will provide strategic regulatory leadership across the development lifecycle of innovative therapeutics.
You will work collaboratively with cross-functional stakeholders to drive patient-focused regulatory strategies, support accelerated development pathways, lead agency interactions, and ensure programs are positioned for successful transition into later-stage development.
Key responsibilities include:
- Providing strategic global regulatory leadership for assigned early development programs
- Developing and executing innovative global regulatory strategies
- Embedding patient-focused approaches into regulatory planning and development strategies
- Serving as a key member of the Early Development Regulatory Team
- Representing Regulatory Affairs within governance committees and development forums
- Partnering closely with asset teams to facilitate seamless transition of programs
- Collaborating with regulatory leadership to establish and enhance processes
- Mentoring, coaching, and developing members of the regulatory organization
- Building and maintaining strong relationships with internal stakeholders
- Monitoring, assessing, and communicating evolving global regulatory requirements
- Leading interactions with health authorities and overseeing external regulatory vendors
- Providing hands-on support for key regulatory submissions and interactions
Requirements:
- 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
- Demonstrated experience supporting innovative therapies through early clinical development
- Proven expertise in developing and implementing global regulatory strategies
- Experience conducting health authority interactions and submissions
- Strong leadership skills with the ability to influence without authority
- Excellent verbal, written, presentation, and stakeholder management skills
- Strong project management, prioritization, and organizational capabilities
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.