PFIZER Assistant Manager - Regulatory Affairs
Regulatory Conformance Manager
Committed to quality and excellence in compliance and
conformance
Accountable for maintaining the corporate change and dossier
management system (PDM) regarding the status of regulatory CMC submissions with
global health authorities per internal SOPs and policies for PEH products.
Ensures timely communication of any issues e.g. Board of
Health queries to the regional teams as needed
Work in collaboration with regulatory colleagues to ensure
(GRL, RRL, CRL & RCM) compliance and deliver efficiencies in the regulatory
submission process.
Responsible for making updates in PDM Market Views for all
submission types except those processed via the MRP/DCP/CP procedure upon
receipt of notification of Submission and Approval evidence
Providing accurate updates in PDM and consult with concerned
colleagues for clarification of any discrepancies, before updating PDM.
Support for updates in PDM for withdrawals of products
registered via MRP/ DCP/ CP
Operate to the highest conformance and quality standards
Operate in line with internal SOPs and policies
Manage status updates of global CMC submissions for the PEH
portfolio within the corporate change and dossier management system
Adhere to standard turnaround timelines
Escalate any potential compliance issues to management
Liaise with regulatory colleagues to communicate and resolve
potential issues
Provide input to continuously improve and streamline the
submission process
Support periodic and ad-hoc system reports to estimate
metrics
Contribute to local and regional regulatory initiatives
promoting a culture aligned with Pfizer values and which supports compliance,
innovation and talent development and retention.
Assist in ensuring internal regulatory processes and
procedures are well documented
Pfizer is an equal opportunity employer and complies with
all applicable equal employment opportunity legislation in each jurisdiction in
which it operates.
Regulatory Affairs
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