Saturday, November 30, 2019

PFIZER Assistant Manager - Regulatory Affairs


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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