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. Career Opportunity Are you lo...
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...
This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labelling commensurate with the available data. Accountable to the asset GRL ...
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 Project Manager will support the agency in managing IT acquisition initiatives throughout all phases of the acquisition lifecycle. Reporting to the Task Order Lead and IT Program Manager, the PM will ensure the successful execution of IT projects within the scope of the contract and according to...
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...
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...
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...
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...
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...
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...
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...
As a Project Manager, you will oversee project objectives, performance benchmarks, and schedule targets. We are currently seeking an experienced Project Manager to join our dynamic team. Develop and maintain infrastructure artifacts, including Standard Operation Procedures (SOPs), System Design docu...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
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...
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...
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. Senior Manager, Regulatory Affairs. This role serves...
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...
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...
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...
The IRB/Compliance Specialist will support MAPMG's Compliance and/or Research Compliance programs by leading the administration of the annual compliance projects. Provide project management support for compliance projects, including the Annual Compliance Plan, Conflict of Interest, and Open Payments...
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 & Regulato...