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. Are you looking for an opportunity to drive inn...
You will primarily assist in the preparation of regulatory submissions for AgNovos’ lead product to ensure compliance with regulatory requirements in the EU, US FDA, and regulatory bodies in other countries. Working with both internal teams and external consultants, you will provide overall re...
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. Career Opportunity Are you lo...
Experience in medical writing, IRB activities, infectious diseases, working with HIV patients, and/or regulatory affairs is highly desirable. Biologics Biotechnology Quality/Risk Management Regulatory Compliance. Conduct regulatory and bioethical reviews of clinical trial protocols, including domest...
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...
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...
Traveling Recertification Specialist - FCRE Compliance and Leasing, LLC. Must have a minimum three (3) years recertification experience with a preference for professional certification(s) such as Certified Occupancy Specialist (COS), Tax Credit Specialist (TCS), or any of the industry HU...
Cherry Hill Programs brings the magic to every experience by capturing moments that last a lifetime. In partnership with retail locations, tourist attractions, and destinations across North America, Cherry Hill Programs contributes millions of holiday and souvenir experiences for children and famili...
In the competitive environment of commercial investment real estate, Bridge has developed a superior team of property management specialists. HUD requirements, compliance reporting and filing audits for the community. Knowledge of HUD and low income compliance A MUST. Conduct property inspections as...
Additionally, the Specialist will provide the appropriate response to all State and Investor audits that occur throughout the year. ...
Project Manager / Technical Lead focused on the planning and engineering design of water infrastructure projects who wants to be part of a purpose-driven organization that's focused on helping our clients, colleagues and communities thrive. You develop project management plans for projects; establis...
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...
Responsible for providing services to the Compliance Group to ensure the corporation's compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Use compliance-related tools to audit, monitor, or gather oversight and compliance data. Coordinate compli...
Work under the direction of the Project Manager to support the planning, coordination, and evaluation of project controls reporting. Be involved in projects with our. Project Controls & Technology Team. Identify, develop, and maintain project control systems for data management across multiple d...
Regulatory Affairs Manager in the Gaithersburg, MD area. As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives. The RAM contributes to regulatory submission strategy, ide...
IT Security Compliance Specialist (0036). IT Security Compliance Specialist. Analyze management and technical controls to ensure that specific security and compliance requirements are met through the verification of documented processes, procedures, and standards in order to validate the maintenance...
The primary responsibility of the Behavioral Compliance Specialist I is to review behavioral client files and claims for accuracy of services related to behavioral service. The Behavioral Compliance Specialist I maintains a comprehensive understanding of ethical principles and independence in their ...
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...
We are seeking a Global Trade Compliance Program Manager to lead our team in ensuring compliance with international trade regulations. As the Program Management Trade Licensing and Compliance Lead, you will be responsible for managing and assessing classification and jurisdiction of program hardware...
The Analyst will play a pivotal role ensuring compliance with federal funding while supporting various components of the Compliance team. Climate United Fund, a 501(c)(3) nonprofit ("Climate United"), is seeking a full-time Compliance Analyst for an entry level position to support adherence to regul...
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 Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory aff...
Ensuring senior level management within the client organization, is aware of overall program status, including all relevant projects and their potential impact on higher level organizational strategic vision, this may include subject matter and unique technical knowledge. Experience applying managem...