Job Description
Committed to quality and excellence in compliance and conformance.
With the reasonable understanding of Regional Regulations, would perform the evaluation of the notifications assigned.
Accountable for maintaining the RA status in corporate change and dossier management system for the allocated Regions / Markets
Contributes independently and manages own time to meet the timelines.
Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
Makes informed decisions on straight cases within guidelines and policies
Operate in line with internal SOPs and policies
Escalate any potential compliance issues to management
Support periodic and ad-hoc system reports to estimate metrics
Assist in remediation activities
Qualifications Must-HavePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory AffairsKeyskills: remediation Quality standards Compliance Project management Consulting Corporate Hardware Regulatory affairs Operations Cost
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