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 activitie

📌 Senior QaRa Coordinator (Gurugram)
🏢 Fresenius Medical Care
📍 Gurugram