• Prepare, review and coordinate, local regulatory submissions;• Provide local regulatory strategy advice (MoH and EC) to clients and team members;• ICF adaptation;• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics;• Participation and monitoring in drug registration processes;• Mentor and coach colleagues as required;• Ensure accurate completion and maintenance of internal systems and client's system, databases, tracking tools, timelines, and project plans with project specific information;• Communication with client, project team members and local regulatory specialists on study sites status, activation projections, risks, and opportunities to secure the activation strategy.

• Assistance in the preparation of reports, amendments, notifications to the EC and MoH;• Monitoring of drug registration processes;• Provide support to the team and the department, maintaining the administrativeorganization of the department;

Responsible Pharmacist