Pfizer HSM, Sr Asso.I in Shanghai, China
The Hub Submission Manager is accountable for operational management of regional and/or national regulatory dossiers to designated Health Authorities (HA's)
Based within WSR Submission Management, this role sits within a team working to tight, business-critical deadlines within a highly regulated environment. Primary focus is on allocated region/ countries, with additional responsibility to support other locations through utilization of global tools.
On behalf of Worldwide Safety & Regulatory (WSR), lead and manage logistical and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers - initial application and subsequent lifecycle updates (compliance and maintenance).
Execute, through use of standards and tools, designated operational tasks e.g. submission planning, document receipt, translation management, technical build and submittal to HA or via the applicable Pfizer country office, conforming to regulatory submission milestones and applicable regulatory obligations.
Given the scope of international work, critical features of this role are the ability to successfully interface with multiple cultures and, to recognize and exploit opportunities to use scale, cloning and repurposing dossiers for worldwide markets where feasible.
C:Plant Clock Standard - 标准工时制 (China)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.