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 HA 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
Support for updates in system for License withdrawals
Operate in line with internal SOPs and policies
Adhere to standard turnaround timelines
Escalate any potential compliance issues to management
Support periodic and ad-hoc system reports to estimate metrics
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
Assist in remediation activities
Support the teams in ADHOC activities
Shares the learning time to time with the team colleagues
Qualification & Experience
Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.