- SMBC (Charlotte, NC)
- …identify strategic opportunities. **Qualifications and Skills** + 15+ years of experience in financial risk management or regulatory reporting within a ... 400-year history, SMBC Group offers a diverse range of financial services , including banking, leasing, securities, credit... Frameworks (CCAR, DFAST, Basel III). + Expertise in Risk Management & Financial Analytics. + Experience… more
- Usaa (Charlotte, NC)
- …relevant experience in risk , compliance, legal or audit within the financial services or insurance industry or specialized technical fields directly related ... our mission is to empower our members to achieve financial security through highly competitive products, exceptional service...regulations, and regulatory expectations. Ability to apply regulatory risk and compliance knowledge o to… more
- Syner-G BioPharma Group (Boston, MA)
- …science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development ... supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We… more
- Usaa (Albuquerque, NM)
- …below. At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. ... of a la cart combinations of various products and services ) based on current products and service ...provide consultative advice and appropriately address and mitigate the risk . Researches industry trends and evolving regulatory … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …global quality organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical and ... initiatives, such as inspection readiness, metrics implementation and review, overall regulatory compliance and implementation programs, and others as required. This… more
- Usaa (Charlotte, NC)
- … risk and compliance principles specific to AI/GenAI initiatives in the Financial Services and Insurance sectors. The ideal candidate will demonstrate AI ... lieu of a degree. 2 years experience in the financial services or insurance industry or specialized...tools, and applicable systems Awareness and ability to apply risk and compliance laws, regulations, and regulatory … more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …with regulatory agencies (FDA, EMA, etc.); support or lead preparation of regulatory submissions (eg, pre-IND, IND, BLA).Contribute to risk assessment of new ... from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific rigor in support of our pipeline of… more
- Merck & Co. (Omaha, NE)
- …Audit, Policy Development, Policy Implementation, Policy Procedures, Problem Solving, Project Risk Assessments, Regulatory Affairs Management {+ 4 more}Preferred ... and related training. The Specialist will interface with internal customers, external vendors, and service providers as needed. This role is a key part of the team… more
- Insmed Incorporated (NJ)
- …teams; translate protocol design into demand/supply plans, contingency strategies, and risk mitigation across global marketsSupport the development and monitoring of ... clinical supply budgets and global financial forecasts (eg comparators, manufacturing demand, packaging & labeling production and distribution)Mentor and manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and implement opportunities for cost savings, process improvements, and risk mitigation.Directly support internal audits, regulatory inspections, and ... CAR-T cell therapy manufacturing site. This includes procurement of materials, services , equipment and capital expenditures (CapEx), ensuring alignment with business… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …controls and maintain permanent inspection readiness and actively support regulatory inspections.Ensure investigations are processing timely according to site ... rationales, and approval for engineering and process changes to meet regulatory requirements.Work closely with cross-functional teams to design and implement cell… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will include but not limited to tasks mentioned above.Support regulatory inspections and audits as needed.Consistently perform tasks in adherence ... and cGMP requirements, as well as according to state and federal regulatory requirements.Other duties will be assigned, as the need arises.Job duties performed… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the interdependent deliverables for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …resulting in the delay of investigation closure and product release.Support regulatory inspections and audits by ensuring inspection readiness within facility and ... serving as an SME during the execution of regulatory inspections and audits as needed.Support compliance activities for site Quality Operations in accordance with… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …will be responsible for reviewing and approving qualification protocols, reports, risk assessments, technical studies, and any associated documentation in support of ... industry standards, and global regulations.Interacts with colleagues in Quality and Technical Services proactively to assess, and guide in the deployment of systems… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …protocols and reportsServe as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change ... industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CAPAs, change controls and complaints.Review and approve manufacturing procedures.Support regulatory inspections and audits by ensuring inspection readiness within ... effectively determine appropriate resolutions that ensure compliance and minimize risk .Must exhibit strong leadership skills and effectively develop others.Ability… more
- Usaa (Charlotte, NC)
- …asap. At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. ... USAA, where our core values honesty, integrity, loyalty and service define how we treat each other and our...effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. Leads a team… more
- Wipfli LLP (Minneapolis, MN)
- …and board and management reporting + Utilize consultative approach to assist financial services clients to develop and strengthen their compliance management ... required. Responsibilities: + Provide pro-active and on-going consultation regarding regulatory compliance risk assessment, remediation, monitoring, research,… more
- Wipfli LLP (Green Bay, WI)
- …and board and management reporting + Utilize consultative approach to assist financial services clients to develop and strengthen their compliance management ... required. Responsibilities: + Provide pro-active and on-going consultation regarding regulatory compliance risk assessment, remediation, monitoring, research,… more
