- VSolvit LLC (Huntsville, AL)
- …internal policies Mitigate Risk Proactively:Identify, quantify, and manage contractual and regulatory risks at every stage of the contract lifecycle Enhance ... as a senior advisor to the CEO, CFO, and COOon contractual and regulatory issues Drive standardization and continuous improvement of contract policies and tools… 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. + ... 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
- GE Vernova (Wilmington, NC)
- …(FMEA), probabilistic risk analysis (PRA), and similar techniques. + Support nuclear regulatory certification or licensing document preparation , + Perform ... Easy5/MSC, Simulink-MATLAB/MathWorks, Mathcad/PTC, 3KeyMaster/WSC, ETAP, SKM], + Change, configuration, document and bill of material (BOM) management [e.g.; ENOVIA/Dassault-Systemes].… more
- Astellas Pharma (Northbrook, IL)
- …global site and country level feasibility, site start up and activation, regulatory and ethics document preparation and submission. **Qualifications** ... and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key… more
- Banfield Pet Hospital (Vancouver, WA)
- …The Paralegal will assist with legal research, litigation management as needed, document preparation , regulatory filings, contracts, and compliance tracking. ... units including Banfield, BluePearl, and VCA. This role will provide regulatory and operational legal support to veterinary hospital operations across multiple… more
- TevisHR (Pleasanton, CA)
- …& Standards: Ensure all documentation complies with company branding guidelines, policies, regulatory standards (eg, ISO). * Audit Preparation : Assist in audits ... the OEM market for nearly 30 years. https://www.quail.com/ Job Title: Document Control Administrator Department: Marketing Job Type: Full-time/Hourly-Non Exempt Job… more
- Fifth Third Bank, NA (Cincinnati, OH)
- …+ Make copies, ensure required documents are included, etc. + Responsible for preparation , quality check and delivery of regulatory file submissions in ... AND RESPONSIBILITIES: + Attend audit meetings and execute on document requests from staff and LOB owners. + Work...+ Organize and maintain file components associated with a regulatory audit. This may include, but not exclusive to,… more
- Golden Route Operations (Las Vegas, NV)
- … Regulatory Manager, you administer and manage gaming licensing and regulatory compliance activities, including the preparation , coordination, and submission ... and internal controls. Essential Functions and Responsibilities: + Oversight of the preparation and submission of regulatory applications of all state and… more
- Exelon (Washington, DC)
- …the analysis to appropriate management. 3. Apply critical analytical skills in the preparation of regulatory data filing requirements for rate case (distribution ... and respond to Commitments tracking inquires and maintenance. Enforce document control policies and deliver training in records and...management (25%) + Provide data and support for the preparation of written testimony, regulatory audits and… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation ... management of other Grifols departments to achieve common business goals as well as regulatory objectives. + Ability to review a document , including labeling, in… more
- LSI Solutions (Victor, NY)
- …will possess strong administrative skills, including proficiency in Microsoft Office, document preparation , and organizing and maintaining a master scheduling ... + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + Assist in review and… more
- Massachusetts Institute of Technology (Cambridge, MA)
- …AUDIT COORDINATOR, Credit Union, coordinates internal and external audits and regulatory exams, including scheduling, document preparation , examiner ... support, tracking findings, and reporting results to senior leadership and the board; performs daily and monthly compliance review activities to ensure validity and fraud prevention across the organization, while assisting the AVP, Compliance with BSA and… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Regulatory Strategist **Location** : Cambridge MA/ Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on to ... accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global...their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading… 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, ... JOB FUNCTIONS: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review...from study activation throughout the completion of the study. Preparation and maintenance of regulatory binders (paper… more
- Ameren (Steedman, MO)
- …more information on benefits provided to regular full-time employees. The Regulatory Affairs / Licensing Engineer provides support to the Callaway Energy Center ... in the areas of regulatory and licensing issues. **Key responsibilities include** ...defense of licensing positions with the NRC. + Coordinate preparation of submittals to change or amend the Callaway… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- CSL Behring (King Of Prussia, PA)
- …regulatory activities as assigned, inclusive of potential to contribute to core document preparation (eg, core briefing book, pediatric plans, etc.), product ... filing preparation activities (investigational, new, and marketed) and health authority...+ Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence. Ensures… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Assist in coordination and preparation for Agency meetings and associated briefing document preparation + Manages and tracks queries and commitments with ... role, a typical day might include the following:** + Coordinate the preparation , submission, management and maintenance of global regulatory submissions related… more
- Sumitomo Pharma (Honolulu, HI)
- …action or develop the appropriate solution + Contribution to the development and preparation of successful regulatory strategies and the ability to contribute to ... for assigned products. This position is responsible for the preparation , coordination and monitoring of routine US and/or global...the development and writing of a regulatory strategy document + Ability to make… 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 ... disease group's Clinical Research Manager in their resolution + Manage the regulatory documentation submissions that may include the preparation and submission… more
