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location: Framingham, Massachusetts
job type: Contract
salary: $53.87 - 63.38 per hour
work hours: 9 to 5
- Ensure on time compilation and dispatch of all country specific information for Fab ICB submission to all global markets, regular follow-up with affiliates to ensure timely submission by then to their HAs. Work with SMEs to ensure timely response to any global HA specific questions to facilitate timely approval of this Fabrazyme supply critical submission.
- Having a focussed resource project manage all global country specific requirements and constant tracking of dispatch, submission and approval timelines, will reduce likelihood of any delays for this submission, particularly markets with longer HA review timelines. More submissions can be managed in parallel, allowing the core team focus on major market submission & approval (critical for those markets that have major market approval as a pre-requisite for filing).
Stage 1: Pre-submission
- Interact with regional and local affiliates to collect regulatory information
- Set up and manage project meetings with local affiliate as needed
- Compile regulatory requirements to ensure completeness and clarity
- Communicate with core project team for status update
- Support core team in the maintenance of global filing plans
- May assist with the planning and preparation of interactions with regulatory authorities by project managing preparation of meeting documents, internal prep meetings
Stage 2: Submission
- Manage and update the global filing plan
- Assist with collecting documents necessary for country specific submissions (SOPs, COAs, Manufacturing Authorizations, notarized documents, declarations, CPPs, etc)
- May address questions and requests from regional and local affiliates
- Track the progress of submissions by getting updates from affiliates
- Assist with responses to questions from Health Authorities by setting up team meetings, as needed, project manage getting responses written, reviewed and content finalized
- Report to the core team of progress of submissions and communicate submission risks
- Regulatory CMC experience
skills: CMC, SOP, MS-EXCEL, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.