Performs eCTD submission management across the companies product portfolio to Health Authorities for global development and lifecycle management submissions. The Regulatory Operations Manager is responsible for the coordination of all publishing deliverables, in line with the strategic direction of their assigned programs/products. Oversee outsourced publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned products.
Acts as the primary point of contact for regulatory functions as appropriate in the products lifecycle. The Regulatory Ops. Manager ensures submission deliverables are incorporated and visible to all stakeholders. Ensures hand offs and deliverables from authoring community are on time and in line with the submission standards and expectations of quality. Drives deliverable timelines with RSM (RA Regulatory Submission Manager) and authoring community and sets appropriate standards and expectations of quality. Responsible for electronic submissions and documents meeting regulatory agency and the companies submission standards and technical requirements. Quality control checks on electronic common technical (eCTD) components, final submissions, hyperlinks and bookmarks, and ensures submissions adhere to local health authority guidelines. Demonstrates expert knowledge of submission or technology-related Health authority guidelines/regulations. Competent in the use of electronic document management and submissions publishing tools. 3-5 years of experience in regulatory operations providing submission delivery support for the US and Europe. Experience overseeing publishing vendors preferred. Pay ranges between $58-65.50/hr based on expereinceTitle: Program Manager Duration: Long term, Type: C2C/Fulltime Job location: Las Vegas NV Position: Program Manager About the Role We are seeking an experienced and dynamic Program Manager to oversee strategic initiatives, drive cross...
We are hiring a Live Chat Agent to manage customer queries and complaints. You will also be asked to process orders, modifications, and escalate complaints across a number of communication channels. To do well in this role you need to be able to remain calm when customers...
...Job Title : Healthcare Data Analyst / Data Governance Job Type : Contract Job Location : Remote Role description : partner with business owners to document end-to-end data flows, including sources, transformations, and business metric definitions...
...Alacrity Solutions is seeking experienced property adjusters to join the Alacrity daily claims team! Skills & Qualifications:... ...travel to location Minimum 2-3 years property experience Independent adjusting license in your home state, or a designated home state...
...oriented people to join our team. We are seeking a Manager Site Reliability Engineer - an individual who is service oriented, delivery focused and can build rapport with key members of the Operations and SRE teams specifying and implementing automation changes, fixes,...