Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization
Job Summary
Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
Prepare and review regulatory submissions, act as a liaison with internal and external clients, and collaborate extensively with other departments and regulatory authorities.
Support business development activities, including project budgeting/forecasting, and provide training and guidance to junior team members.
Matching Summary
Provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
Skills & Requirements
Must-have
regulatory intelligence and guidance
regulatory submissions preparation
client liaison and communication
ICH and global regulatory guidelines
medical terminology and statistical concepts
Nice-to-have
strategic product development support
business development activities
Key Requirements
Bachelor's degree or equivalent
5+ years of relevant experience
Strong English language skills
Solid computer skills
Solid organizational and time management skills
Solid understanding of global regulatory requirements