Description
The Data & Conformance Manager role focuses on interpreting, managing, and ensuring the quality, accuracy, and proper management of global regulatory data and conformance activities.
Responsibilities:
- Review and interpret data provided by GRS to establish the system/tools required to be populated in line with current standard operating procedures or business process documentation.
- Maintain HA status in corporate change and dossier management system for allocated Regions/Markets.
- Make updates in regulatory systems for all CMC events upon receipt of notification of Submission and Approval evidence.
- Perform data entry and quality control tasks associated with all global regulatory systems impacted.
- Adhere to quality control procedures and standards related to systems or tools ensuring Regulatory Compliance.
- Support global/local team members with data management workload when necessary.
- Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values.
- Assist in ensuring internal regulatory processes and procedures are well documented.
- Support teams in ADHOC activities, including assisting presentations/review of metrics.
- Make timely decisions on straightforward cases within guidelines and policies.
Work Location Assignment: Hybrid
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