Company DescriptionObjectWin provides global workforce solutions to meet current and future business demands of our customers. Our services include, various workforce solutions, SOW based projects and fulltime resource deployments. We serve our customers both nationally and globally.Job Description Job Title: CMC Regulatory Affairs Project ManagerDuration: 6 MonthsJob Location: 333 Lakeside Drive, Foster City, CA 94404No Remote, No C2C – USC/GC holders onlyDescription: The CMC Regulatory Affairs Project Manager will be responsible for tracking the status of key filings for clinical and commercial programs for all global markets. The Project Manager will communicate with the cross functional CMC teams on small molecule and biologics submissions tracking. The Project Manager will attend CMC regulatory meetings and will be responsible for maintaining timelines, meeting minutes, action items, resource plans and other project documents.Job Responsibilities:Facilitate communication of regulatory activities across CMC Sub-Teams and Senior ManagementWork on an improved tool for the regulatory department to track submissionsGenerate metrics on regulatory submissions and approvals across a wide-array of submission subtypes.Tracking of regulatory filings for clinical and commercial programs for all global marketsDevelop and manage detailed project timelines for regulatory activitiesMonitors project execution and adjusts plansFacilitates communication and documentation of regulatory activities across project teams and senior managementCollaborates with the team to resolve issues and organizes team to execute on the corrective actionsEnsures project work complies with established practices, policies and processes Qualifications Minimum 6 years of relevant experience and a BA or BS or 4 years of relevant experience and a MS or MBA. Relevant experience consists of work in cross functional biopharmaceutical /pharmaceutical CMC development, GMP and regulatory affairsExcellent organizational skills, capable of setting priorities and delivering on commitments, while managing high workloadStrong communication skills; written and verbal including oral presentation skillsExperience in regulatory CMC project management is preferredIn-depth knowledge and skill with Microsoft Project, Excel, PowerPoint, Word, Visio, SharePoint and other reporting/tracking tools Additional InformationIf this position be of interest to you, please contact me directly at 832-485-3662