FSP Country Approval Specialist - fully client dedicated Denmark and Sweden

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions: Office Job Description: Join Us as a Senior Country Approval Specialist - Make an Impact at the Forefront of Innovation 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 (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 wi...