Senior Country Approval Specialist

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 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 regulatory authorities to ensure submissions are managed in a timely manner. Act as a key-contact at country level for all submission-related activities. Participate as required in Submission Team Meetings, Review Meetings and Project Team meetings. Coordinate with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are aligned to the critical path for site activation. Achieve company’s target cycle times for site activations. Prepare the regulatory compliance review packages, as applicable. Liaise wi