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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
This position is responsible for planning, prioritizing, and organizing compliance tasks for clients including Policy and Plan Document Coordination, Non-Discrimination Testing, Form 5500 and SAR Preparation, Health Care Reform compliance, other health and welfare compliance needs. Maintain accurate...
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...
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 with the...
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 Director of Regulatory Affairs will be responsible for leading the regulatory function, creating and executing compliance strategies to meet both business needs and regulatory standards. Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory...
Provide oversight in the monitoring, identification, and resolution of day-to-day IC facilities issues, including those related to energy, environmental compliance, Military Construction, facilities program management, and climate change. Serve as principal advisor, consultant and advocate for IC en...
Associate Director, Regulatory Affairs CMC Associate Director, Regulatory Affairs CMC. ...
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, complianc...
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...
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...