Key Responsibilities:

Regional Coordination and Reporting
• Coordinate with QaRa teams across Asia Pacific countries to track project timelines, deliverables, and action items.
• Consolidate and prepare periodic reports on regulatory, quality, and compliance activities across APAC.
• Support regional initiatives by monitoring progress and ensuring timely completion of assigned tasks.

Pharmacovigilance Support
• Prepare and consolidate drug product sales reports for individual APAC countries to support pharmacovigilance reporting requirements.
• Support the Regional Drug Safety Manager in the administration and coordination of drug and medical device safety case reviews.
• Maintain records and documentation related to pharmacovigilance activities.

Regulatory Affairs Support
• Support Regional Regulatory Managers in coordinating labeling updates for pharmaceutical and medical device products.
• Maintain change control trackers and follow up with country affiliates regarding implementation status and feedback.
• Assist in the preparation, review, and management of regulatory documentation and reports.

Project Coordination
• Provide project management and administrative support for regional regulatory and quality initiatives.
• Coordinate meetings, prepare meeting minutes, track action items, and ensure follow-up on commitments.
• Collaborate with internal stakeholders to support successful execution of regional projects.

Data and Document Management
• Maintain and update databases, trackers, spreadsheets, and electronic records.
• Prepare, review, and format reports, presentations, and other business documents.
• Ensure accuracy, completeness, and timely availability of records and documentation.

Records Management and Compliance
• Maintain organized electronic and physical filing systems in accordance with company policies.
• Ensure proper retention, retrieval, and protection of confidential information.
• Support document control and record management activities as required.

Administrative Support
• Provide administrative support to the APAC QaRa leadership team, including:

• Vendor management and payment coordination
• Meeting scheduling and calendar management
• Travel and expense coordination
• Preparation of presentations and departmental communications