Regional Submission Manager -homebased In Bulgaria
ICON Clinical Research, LP
Bulgaria
Global submission management strategy
Cta submission development
High quality compliant submissions
Drive global submission management strategy and activities for assigned protocols, partnering with study teams to manage regulatory activities associated with CTA submission development
Job Summary
Drive global submission management strategy and activities for assigned protocols, partnering with study teams to manage regulatory activities associated with CTA submission development.
Support and lead global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.
Matching Summary
Drive global submission management strategy and activities for assigned protocols, partnering with study teams to manage regulatory activities associated with CTA submission development.
Skills & Requirements
Must-have
Global submission management strategy
CTA submission development
High quality compliant submissions
Health Authority (HA) submissions
Clinical Trials Information System (CTIS)
Nice-to-have
Foster an inclusive environment
Drive innovation and excellence
Shape the future of clinical development
Key Requirements
B.S./B.Sc in Pharmacy, Life Sciences, Business or IT (desirable)
Equivalent relevant professional experience considered
In-depth understanding of CTA and Central Ethics processes
Proven technical aptitude and ability to learn new software