Senior/Principal - Country Approval Specialist

Job Title: Senior/Principal - Country Approval Specialist Job Location: Remote, North Carolina, United States of America Job Location Type: Remote Job Contract Type: Full time Job Seniority Level: Environmental Conditions: Office Work Schedule: Standard (Mon-Fri) Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Senior/Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation The Senior/Principal 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 (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy. • Provide local regulatory strategy advice (MoH &/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 communications with investigators, and with the country