Basic Section

Organisational

Skills

Skill

Education Specialization

Minimum Qualification

Job Description

• KEY RESPONSIBILITIES. Operational ExcellenceSite RegistrationFacilitate the approval of manufacturing sites in targeted countries by coordinating site registrations and inspections as per local requirements.Product Dossier Submissions Ensure the submission of product dossiers (both in-house and outsourced) in selected countries.Coordinate with internal teams to gather and manage all necessary documentation for timely submissions.Lifecycle ManagementManage the application of variations and updates to already registered dossiers in respective countries, ensuring compliance with regulatory changes.Dossier Planning & Documentation Plan and oversee dossier submissions by managing required documentation across all product types and markets.Maintain version control and ensure documentation is audit-ready at all times.Management Information Systems (MIS)Maintain centralized documentation and regulatory records for the entire team to ensure easy access and data integrity.Team Performance ManagementOversee and manage the performance of the regulatory team by allocating work according to total active projects and monitoring progress.. Customer ExcellenceQuery Filing and Response Management Address regulatory queries received from Ministries of Health (MOH) or partners by guiding the team on appropriate responses and timelines.Ensure quality and completeness in all query responses and maintain effective communication with stakeholders.. Quality ExcellenceTraining & Development Continuously develop leadership and regulatory competencies within the team.Participate in leadership training programs and encourage knowledge sharing..