Regulatory Affairs -Export - Executive
KEY RESPONSIBILITIES 1. Operational Excellence- Site Registration
Facilitate 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 150 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 Management
Manage 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 Management
Oversee and manage the performance of the regulatory team by allocating work according to total active projects and monitoring progress.
2. Customer Excellence- Query 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.
3. Quality Excellence- Training & Development
Continuously develop leadership and regulatory competencies within the team.
Participate in leadership training programs and encourage knowledge sharing.
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