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The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy.
What You'll Do:
• Prepare, review and coordinate local regulatory submissions (Mo H, EC, additional special national local applications if applicable in alignment with global submission strategy.
• Provide local regulatory strategy advice (Mo H &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Serve as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.
• Ensure guidelines and processes are followed for effective internal team communications as well as co...