Quality Assurance Specialist (Regulatory) CVPF(Center for Cellular Immunotherapy). The Quality Assurance Specialist will work within the Clinical Cell and Vaccine Production Facility (CVPF) for the review and release of investigational cell and gene therapy products for human administration manufact...
As a Senior Specialist, you’ll be at the forefront of regulatory affairs, working with cross-functional teams to manage and oversee submissions, compliance, and regulatory project strategies. Senior Specialist, Regulatory Project Management. Lead cross-functional regulatory projects for device submi...
Day in the life: Support manufacturing and supply, ensure regulatory requirements are met, update product dossier, technical authoring, look at technical docs and author regulatory change, interpret results. Vault Rim system in a bonus, or system that houses quality docs and regulatory submission. R...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 - $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
Develop and oversee the FGO Financial and Regulatory framework programs•Set Financial and Regulatory Framework Methodologies and Expectations, including Materiality Thresholds & qualitative considerations•Perform 2LOD review, challenge, and governance (ex: control framework challenge, administering ...
Collaborate with regulatory lead(s), cross-functional project manager(s) and SMEs (Subject Matter Experts) in R&D, quality assurance, clinical affairs, labeling, and more to align on deliverables for global submissions, establish key regulatory positions, and to ensure product development and lifecy...
Actively participates and leads the organization's efforts to prepare for, take part in and respond to any necessary follow-up of both announced and unannounced regulatory body site visits with a focus on the Clinical Practices of the University of Pennsylvania. ...
Environmental Regulatory Specialist. For the Managing Consultant, Environmental Regulatory Specialist (Senior Level) position, we anticipate the annual base pay of $76,000 – $94,860 (USD). Federal Energy Regulatory Commission (FERC). Research, analyze and compile data for permit applications and rep...
This Senior Specialist, Regulatory Project Management (RPM) role is responsible for management of regulatory affairs projects associated with West’s global portfolio of medical devices, combination products, SaMDs, and packaging components. Collaborate with regulatory lead(s), cross-functional proje...
As a Regulatory Risk Specialist within PNC Investments organization, you will be based in Philadelphia, PA or Bridgewater, NJ. Partners with regulatory risk manager to execute regulatory risk initiatives including setting up, building and monitoring initiatives. Participates in regulatory and audit ...
Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing review...
The Corporate Information Services Department is seeking a dynamic and talented Senior Clinical Informatics Specialist. The Senior Clinical Informatics Specialist provides guidance in identifying, developing, implementing, and maintaining an efficient and effective clinical information system. ...
The Clinical Research Regulatory Specialist is expected to facilitate the development of grant and clinical trial submission of applications and annual reports, development/maintenance of study-specific case report forms and source document tools, provide direct regulatory/compliance guidance, and f...
This position has several primary functions and/or responsibilities:1) Responsible for developing and executing process validation protocol for aNDA product.Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product.Initiate investigation in prob...
This position has several primary functions and/or responsibilities:1) Responsible for developing and executing process validation protocol for aNDA product.Perform quality control testing and production of aNDA products and become subject matter expert in aNDA product.Initiate investigation in prob...
The Corporate Information Services Department is seeking a dynamic and talented Senior Clinical Informatics Specialist. Senior Clinical Informatics Specialist. ...
This team manages and oversees interactions with regulatory agencies to ensure that Vanguard is positioned to mitigate regulatory risk. Vanguard has an exciting opportunity for a Compliance Specialist. This role is an individual contributor that is responsible for collaborating with business partner...
Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the NCI/NCTN Senior Regulatory Affairs Study Start-Up Specialist will prepare and process, independently all initial oversight submissions regulatory documentation through the Penn IRB/CIRB, CTSRMC, and all applicable regulat...
Reporting to the Regulatory Affairs New Study & Continuing Review Manager, the NCI/NCTN Senior Regulatory Affairs Study Start-Up Specialist will prepare and process, independently all initial oversight submissions regulatory documentation through the Penn IRB/CIRB, CTSRMC, and all applicable regulat...
Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs Specialist-CC will, with minimal supervision, prepare and process all regulatory documentation through the IRB, CTSRMC, FDA and all applicable regulatory review committees- including new submissions, continuing review...