- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, Webex, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... programs and resources, and much more. Posted Job Title Associate Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job… more
- Takeda Pharmaceuticals (Boston, MA)
- … authoring, submission publishing/validation/viewing, registration and commitment tracking, and regulatory document archiving. + Experience with regulatory ... knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global Regulatory...regulatory processes and technology for submission document… more
- Dana-Farber Cancer Institute (Boston, MA)
- …compliance for the disease group. Implementing systems to monitor and ensure regulatory document collection and maintain compliance and audit-ready state. Assist ... relevant to children with cancer and blood disorders. CTIP Regulatory unit will provide pan-CTIP support as part of...support as part of our clinical research infrastructure. CTIP regulatory unit will support interventional studies to the IRB… more
- Actalent (Miami, FL)
- …and Engineering. RESPONSIBILITIES: * Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, ... Keeps abreast of regulatory procedures and changes. Skills Regulatory affairs, Regulatory , document control, bilingual, fda, medical device, RAPS… more
- University of Miami (Miami, FL)
- …provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, ... studies: JOB FUNCTIONS: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study activation… more
- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site… more
- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site… more
- Roche (Indianapolis, IN)
- …global markets, primarily the US and Europe. **The Opportunity** + You oversee regulatory document and submission compilation, which includes the development of ... love. That's what makes us Roche. At Roche Global Regulatory Affairs we strive to be the world's best... Affairs we strive to be the world's best Regulatory organization, championing patient access to the world's best… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... and Execute the Global Regulatory Strategy - Initiate and Update Regulatory Strategy Document (RSD)_ + Obtain input from the global regulatory team… more
- Sumitomo Pharma (Honolulu, HI)
- … strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to make complex decisions and willingness to ... highly motivated, and experienced individual for the position of **Associate Director, Regulatory Affairs (Oncology).** The Associate Director is part of the Global … more
- ICON Clinical Research (NC)
- …experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical ... Senior Manager, Regulatory Affairs - IVD ICON plc is a...to shape the future of clinical development. Sr Manager, Regulatory Affairs - IVD Location: US Remote, Portland, OR… more
- AECOM (Sacramento, CA)
- …archival activities to ensure compliance with standards, contractual requirements, and regulatory obligations + Ensure adherence to document control procedures, ... management (eg, CDIA+, CRM) or equivalent + Familiarity with audit processes, regulatory compliance, and document retention requirements + Experience supporting… more
- Kelly Services (Philadelphia, PA)
- …workflows and documentation guidelines. + Draft and ensure high quality technical regulatory documents + Create electronic document versions (Word, PDF, etc.) ... + Import/export documents into Veeva Regulatory One following document management rules + Define metadata (properties) for each document and align according… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …product lines, aligning with overall business objectives. + Review, approve, and document regulatory changes to commercialized devices. + Identify and ... Summary** This position will be working in BD-Connected Care on Regulatory Affairs projects that support the Pharmacy Automation business. This role… more
- ACLD (Bethpage, NY)
- …throughout Nassau and Suffolk Counties. Essential Functions + Conduct and document Regulatory Affairs activities including Billing and Documentation reviews ... Regulatory Affairs Analyst When a group of families...we support. Primary Purpose of Job Assess and support regulatory compliance and the quality of service delivery systems.… more
- Actalent (Fountain Valley, CA)
- …and submissions up to date. + Serve as the go-to person for routine regulatory tasks, including document preparation, updates, and compliance checks. + Prepare ... Job duties: + Maintain accurate paper-based regulatory files for all clinical studies, ensuring compliance...+ Act as a liaison between the PI and regulatory bodies, providing updates and clarifications as needed. +… more
- Insight Global (Pleasant Prairie, WI)
- …securely stored, and readily retrievable in compliance with applicable standards and regulatory requirements. - Manage the document change processes, ensuring ... FSSC 22000, FDA (21 CFR part 820), and applicable regulatory standards. - Train internal teams on document... regulatory standards. - Train internal teams on document control procedures, change management workflows, and regulatory… more
- LSI Solutions (Victor, NY)
- …assigned. Level II + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + ... opportunity for you to take that skillset and branch out into the area of regulatory . We are seeking a person who is highly organized and detail-oriented to become a… more
- TECO Energy (Tampa, FL)
- …Energy Sector Pipeline Regulation Case Management Federal and State Regulations Document Submission Regulatory Research Stakeholder Liaison Data Analysis ... Title: Regulatory Coordination - Lead Company: **Peoples Gas System**...and annual submissions (such as petitions, tariffs, testimony, interrogatories, document production, and data requests) for Peoples Gas System,… more
- ThermoFisher Scientific (Greenville, NC)
- …program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry ... of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and… more
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