Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
Position Overview We are seeking a Senior Regulatory Affairs Specialist to lead the development of Standard Operating Procedures (SOPs) and Working Practice Guidelines (WPGs) for managing Data Safety Monitoring Boards (DSMBs) within an electronic DSMB management system. Collaborate with cross-functi...
The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
The Director of Regulatory Strategy is responsible for shaping and executing regulatory strategies for clinical development programs and regulatory submissions across multiple therapeutic areas. The Director of Regulatory Strategy will lead and oversee the implementation and optimization of the Docs...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
The incumbent will serve as an inter-agency consultant on compliance-related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
Reporting to the Chief Compliance Officer, the IRB and Compliance Specialist will support the organization’s Compliance department and the Institutional Review Board (IRB) activities. Provide project management support for compliance initiatives, including monitoring and audit in accordance wi...
HIAS seeks a Budget & Fiscal Compliance Specialist, North America to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure in the United States and overseas. Manages reporting, compl...
HIAS seeks a Budget & Fiscal Compliance Specialist, U. Manages reporting, compliance and recognition of U. Programs and the Budget & Fiscal Compliance teams to assist affiliates on all financial agreements, monitoring and reporting, including creation of financial reporting workbooks for aff...
The incumbent will serve as an inter-agency consultant on compliance-related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
Additionally, the Specialist will provide the appropriate response to all State and Investor audits that occur throughout the year. ...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. Play an active role in supporting the execution of key projects within the International Government & Regulatory A...
Performance Management Data Analyst ) who will be responsible for the compliance monitoring of the retirement benefit process of the Montgomery County Employee Retirement Plans. Overseeing the third party recordkeeper, related to corrections of employee accounts, outside agency contribution reconcil...
Program Manager to provide program management and implementation support to help integrate unit-level services, set the strategic direction, develop business architectures, conduct IT funding evaluation, and support execution of the multi-year planning process. The ideal candidate will have extensiv...
We seek an experienced Assistant Project Manager with commercial construction to join our team! You will oversee project planning, scheduling, budgeting, and implementation. Are you an Assistant Project Manager with 3-5 years experience?. Our employees will tell you that we offer a great working env...
The Leidos Digital Modernization Sector Health IT Division is seeking a skilled Infrastructure Program Manager (PgM) with hands on experience leading technical teams in delivery of a full range of IT Infrastructure and Operations services in Amazon Web Services (AWS)) for Federal Health customers. B...
Within CVRM Regulatory Affairs we take innovative regulatory approaches to bring these CVRM life-changing treatments to those who need it – working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. In Regulatory Affairs, our teams influ...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
Assist project owners manage financial aspects of project to include monitoring budget, projecting future spending and completing appropriate financial requests and accounting documentation. Research new trends in project management and related project management software and applications to improve...
The Senior Regulatory Affairs Manager partners with senior regulatory leadership on the development of regulatory strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions and department activities. This role serves as a Regulatory Affairs representat...
Ideally assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the assigned asset and the impact this will have on the regulatory strategy. Accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate (regional) regulatory stra...
Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. Ideally assess precedent, regulatory intellig...
Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. Ideally assess precedent, regulatory intellig...