Project Manager - Regulatory Affairs

Foster City, CA
Jan 23, 2019
Required Education
Associate Degree
Position Type

Title: Project Manager, Regulatory Affairs
Location: Foster City, CA
Type: Contract

Implement, maintain and support projects and solutions to enable collaboration, information generation and data reporting across PDM.

  • Provide assessment and decision making support for various suitable tools
  • Gather business requirements and critical design parameters to be included from the stakeholder groups
  • Design visualizations and all technical elements to meet the business requirements
  • Work with technical team as necessary to develop the tool to desired specification and initiate go-live
  • Support go-live and all post go-live requirements (e.g., training, trouble shooting etc.)
  • Develop performance metrics/KPI to monitor usage, TAT, adherence, etc
  • Facilitate the gathering of user requirements for improvements to business process or tools
  • Design, test and assist in the deployment of enhancements and provide training to stakeholders
  • Develop communication, report progress and metrics on a routine basis

Regulatory Affairs Support

  • Work closely with regulatory affairs to support global submissions
  • Track all global submissions
  • Track shipping of global submissions
  • Excellent knowledge of Sharepoint
  • Manufacturing Regulatory Affairs experience
  • Perform routine tactical/operational tracking and reporting
  • Support for Knowledge Management and various SharePoint building initiatives as necessary
  • Support for various PDM PM PMO development efforts as necessar
  • Support for PDM Supply Chain OPEX project as necessary by supporting optimization efforts - reporting options, data analytics