**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Summary of Essential Functions:**
The primary responsibilities include coordinating and managing local regulatory and ethics submissions in alignment with global strategies, providing regulatory strategy advice and technical expertise, and serving as the primary contact for investigators, ethics committees (EC), and regulatory authorities (RA). The role ensures effective communication and timely management of submissions, supports and manages Informed Consent Form (ICF) negotiations and approvals, and achieves set cycle times for site activations while maintaining accurate trial status information.
**Key responsibilities:**
+ Prepare, review, and coordinate local regulatory submissions (EC, additional special national local applications if applicable, e.g. therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy for the ini...