7 days old

Sr. Regulatory Effectiveness Manager

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This role should

+ Be responsible for the regulatory SoP/guidance development, update, maintenance and related training. To streamline working procedure with the internal and cross-functional departments in order to achieve the work efficiency and effectiveness. Ensure the regulatory compliance with the Good Regulatory Practice as well as to meet global and local regulatory requirements.

+ Understand company's compliances policy, and to manage the daily team activity to align with these accordingly.Summary of the Job's main purpose:

+ Work closely with global functional team and local related functional team to understand the policies, guidelines and SOPs;

+ Be accountable for coordinating China RA guidance and SOP development and update, being responsible for guidance and SOP maintenance;

+ Facilitate the process improvement in regulatory team and cross-functional;

+ Be accountable for the preparation of the local regulatory Affairs team for self-audit/audits/inspections;

+ Provide and facilitate the timely training to local Regulatory Affairs team on policy, guidance and SOPs to ensure the compliance; and other technical training programs to improve the competence on regulatory skills;

+ Work with global functional team as well as local team to identify and design the training programs to enhance regulatory competence of the local team

+ Being responsible for orientation programs for local new staffs;


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs
Posted: 2020-10-13 Expires: 2020-11-13
Sponsored by:
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Sr. Regulatory Effectiveness Manager


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