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-Have - Bachelor's Degree
- Demonstrated experience
- Proven ability to consistently deliver to time, cost and quality standards
- Operational knowledge of hardware and software tools required for the job
- Excellent organizational skills and attention to detail
- Knowledge of documentation practices
- Fluent in English, verbal and written
Nice-to-Have - Project Management experience
- Knowledge across multiple therapeutic areas
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
