Country Approval Specialist

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Essential Functions and Other Job Information: Prepare, review and coordinate local regulatory submissions in alignment with global submission strategy. Provide, under guidance, local regulatory strategy advice (MoH &/or EC) to internal and external clients. Provide project specific local SSU services and coordination of these projects. Have contact with investigators for submission related activities. Act as key-contact at Country level for Ethical and Regulatory submission-related activities. Coordinate, under guidance, with internal functional departments to ensure various site start-up activities aligned with submissions activities and mutually agreed upon timelines; ensured alignment of submission process for sites and study are aligned to the critical path for site activation. Prepare regulatory compliance review packages. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years). Working Conditions and Environment: Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves. #J-18808-Ljbffr