Regional Submission Manager -homebased In Bulgaria
ICON
Multiple Locations, ,
Global submission management strategy
Cta submission development
Regulatory compliance and standards
As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team
Job Summary
As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.
ICON offers a range of benefits focused on well-being and work-life balance, including health insurance, retirement planning, and a global employee assistance program.
ICON is committed to providing an inclusive and accessible environment for all candidates and a workplace free of discrimination and harassment.
Matching Summary
As a Manager, Regulatory Affairs at ICON, you will play a pivotal role in contributing to drug development as part of the Regulatory Affairs team.
Skills & Requirements
Must-have
Global submission management strategy
CTA submission development
Regulatory compliance and standards
Clinical trial regulatory activities
Regulatory document translation coordination
Nice-to-have
Proactive RFI processing
Financial transaction management
Local country liaison experience
Strong communication and coordination
Ability to learn new software quickly
Key Requirements
B.S./B.Sc in Pharmacy, Life Sciences, Business or IT
In-depth understanding of CTA and Central Ethics processes
Proven execution of regulatory submission activities