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.
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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.