Senior Country Approval Specialist

Senior Country Approval Specialist

Join us as a Senior Country Approval Specialist and play a pivotal role at the forefront of our innovative regulatory processes. In this strategic position, you will manage the preparation, review, and coordination of Country Submissions, ensuring alignment with our global submission strategy.

• Prepare, review, and coordinate local regulatory submissions, including MoH, EC, and special national applications, in line with our global strategy.
• Provide regional regulatory strategy advice to internal clients and develop local submission strategies.
• Serve as the primary contact for investigators and local regulatory authorities, ensuring submissions are managed efficiently and effectively.
• Coordinate with internal departments to align submission processes with site start-up activities and critical path timelines.
• Prepare regulatory compliance review packages and maintain accurate trial status information in our database.
• Liaise within our organization to ensure local submission activities align with global project strategies.
• Develop country-specific Patient Information Sheet/Informed Consent form documents and assist in grant budget negotiations.
• Mentor and support other team members as needed and proactively identify and resolve regulatory process issues.

To excel in this role, you will need a Bachelor's degree or equivalent, along with at least 3 years of relevant experience. Fluency in Arabic and English, excellent communication skills, strong attention to detail, and a solid understanding of SFDA and regional/national regulatory guidelines are essential. A basic knowledge of medical/therapeutic areas and medical terminology is also beneficial.