- Fresenius Medical Center (Tampa, FL)
- …maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information ... AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to… more
- Pacificorp (Portland, OR)
- …are archived accurately in the data management system; and maintain the regulatory document center. Compile and organize information from multiple sources; ... Sr Regulatory Operations Coordinators (Portland, OR / Salt Lake...of five years of administrative experience including project and document management, or related areas. + Proficient use of… 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 facilitate investigator initiated trials and investigator-initiated multi-site… more
- University of Miami (Miami, FL)
- …include, but not be limited to: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study ... has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department...CORE JOB SUMMARY: The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting… 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, ... review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Remote SCCC Regulatory Analyst II reviews, prepares, and provides oversight for… more
- University of Pennsylvania (Philadelphia, PA)
- … document tools, as well as, to provide direct regulatory /compliance guidance and oversight of investigator-initiated trials and investigator-initiated multi-site ... to Sponsors, Investigators, Manufacturers, and Labs + Write and edit regulatory submission document , sponsor support tools and SOPs + Conduct Sponsor Training… 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 ... the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative… more
- Takeda Pharmaceuticals (Boston, MA)
- …CTN, IND, CTA, PSP, PIP, 15-day safety notifications, and rapid response document ; Submission planning and management of Regulatory submissions: Collaborate with ... Regulatory EDMS and business development support: Provide end-user support for Regulatory electronic document management system (EDMS); Create job aids to… more
- Lilly (Indianapolis, IN)
- …could impact the global product strategy or brand. + Enable discussion of the regulatory strategy document and regulatory issues/challenges at the ... the world. **Purpose:** The purpose of the Senior Director, Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … Regulatory Affairs team(s) to align the IT architecture to facilitate regulatory submissions, document management, and compliance tracking and to ensure ... . **Job Description** The Lead Enterprise Architect (Product Development & Regulatory Compliance) is responsible for developing a forward-looking technology strategy… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Ability to work collaboratively in cross-functional teams. + Proficiency with regulatory databases, document control systems, and project management tools ... self. Become a **maker of possible** with us. **Overview** As Staff Specialist, Regulatory Affairs, you will develop and implement medical device regulatory … more
- Citigroup (Irving, TX)
- …report data assurance for all risk reports supporting Risk CRO and Risk and Regulatory management + Document requirements for improving Retail Credit Risk and ... for risk management strategy/execution oversight for compliance with Citi Policies and Regulatory requirements, and driving Strong Risk Management - for USPB Risk,… more
- System One (Pittsburgh, PA)
- …(SOPs), batch records, and other forms according to company standards and regulatory requirements. + Electronic Document Management System (EDMS): Manage the ... Job Title: Document Specialist Location: Onsite/Pittsburgh, PA 15219 Type: Direct-Hire Start date: End of May Overview: Join an innovative biotech team at the… more
- ThermoFisher Scientific (Austin, TX)
- …and provide active and ongoing regulatory guidance to project teams + Document regulatory strategies for product submissions. + Facilitate and prepare US ... **Responsibilities:** Join Thermo Fisher Scientific Inc. as a Manager, Regulatory Affairs, and play a pivotal role in molding...Affairs, and play a pivotal role in molding our regulatory strategies! + Responsible for providing guidance to ensure… more
- NRG Energy, Inc. (Houston, TX)
- …participate in facility inspections and compliance certifications; participate in and document regulatory agency facility inspections. + Provide environmental ... compliance programs, focusing primarily on environmental data and reporting, regulatory compliance, obtaining project related permits, renewal of existing permits,… more
- Fujifilm (Thousand Oaks, CA)
- …and ensure security of all documentation. + Support project teams in document compilation and submission for regulatory approvals. + Participate in ... diploma with 11+ of applicable industry experience + Strong understanding of regulatory requirements associated with document management. + Proficiency with … more
- Actalent (Irvine, CA)
- …that our products and processes meet the highest standards of quality and regulatory requirements. Key Responsibilities Document Control: Manage and maintain all ... Description We are seeking a detail-oriented and experienced Document Control Specialist to join our team. In this role, you will be responsible for managing and… more
- Actalent (Irvine, CA)
- …that our products and processes meet the highest standards of quality and regulatory requirements. Key Responsibilities + Document Control: Manage and maintain ... Job Title: Document Control Specialist Location: Irvine, CA Job Family...Ensure all documentation is accurate, complete, and compliant with regulatory standards. + CAPA (Corrective and Preventive Actions): Implement… more
- Aston Carter (Thousand Oaks, CA)
- …to day responsibilities: 1. RI Gathering, Monitoring & Surveillance. Identify and document key regulatory requirements for global submissions. Track updates from ... Description Fully remote- PST working hours are preferable Global Regulatory Policy and Intelligence engages regulators industry and professional associations and… more
- JPMorgan Chase (Brooklyn, NY)
- …and implementation considerations + Provide technical interpretation & guidance on regulatory reporting issues and document interpretations of complex ... The Regulatory Reporting Policy team sits within Corporate Finance...(BCAPR), consisting of the Bank Controller, Corporate Accounting Policy, Regulatory Reporting Policy, Inter-entity Analysis, Quality Review & Control… more
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