Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval
Job Summary
Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
Lead and facilitate the global/regional labeling working groups to support the development of core and major regional labeling.
ICON offers a range of additional benefits focused on well-being and work life balance, including various annual leave entitlements, health insurance, retirement planning, and a Global Employee Assistance Programme.
Matching Summary
Provide regulatory expertise to drug development teams on the development and submission of labeling components for regulatory agency approval.
Skills & Requirements
Must-have
Global labeling strategy
Regulatory agency approval
Labeling content consistency
Core labeling content implementation
Global/regional labeling working groups
European labeling components
Nice-to-have
Inclusive environment
Innovation and excellence
Diverse and dynamic team
Well-being and work life balance
Key Requirements
Bachelor's degree in scientific discipline
Minimum 8 years experience
Regulatory affairs or labeling experience
Pharmaceutical or biotechnology industry experience
Strong understanding of global regulatory requirements