Country Approval Specialist

Overview

Country Approval Specialist to support preparation, review, coordination, and submission activities for country submissions in line with global submission strategy.

What you'll do

• Prepare, review, and coordinate country submissions with guidance and local EC submissions.
• Support preparation of local MoH submissions as applicable.
• Coordinate with internal functional departments to align site start-up activities with submission timelines.
• Achieve company target cycle times for site activation.
• Support regulatory compliance review packages with start-up CRA(s) as applicable.
• Enter and maintain trial status information for SIA activities in tracking databases.
• Assist with patient information sheet/informed consent form document development.

What you'll need

• Relevant bachelor’s degree or equivalent qualification.
• Comparable 0 to 2 years of prior experience (or equivalency via education/training/experience).
• Effective oral and written communication skills.
• Strong attention to detail and quality of documentation.
• Good negotiation skills.
• Good computer skills and ability to learn appropriate software.
• Basic knowledge of applicable regional/national regulatory guidelines and EC regulations.

Details

• Work schedule: Mon–Fri.
• Work mode: Remote, India.