Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc. Experience in preparing regulatory documents, publishing regulatory submi...
The Regulatory Compliance Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The Regulatory Compliance Specialist ...
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...
Regulatory Health Communication Specialist, Mid. As a regulatory health communication specialist on our team, you’ll impact the development of creative solutions to complex public health challenges and priorities. ...
Ensures that protocol and regulatory documents are maintained and are kept up to date. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC, and HJF. Maintains complete and accur...
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 ...
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 looking for a regulatory leadership role where you can build advocacy and accelerate product development and licensure on a global scale, but with a focus on US? If so, this Director, Global Regulatory Affairs, Vaccines role could be an exciting opportunity to explore. As a Director, Regulat...
We are seeking a Section 508 Compliance Analyst to provide support in managing, consulting and ensuring information and communication technology activities integrate appropriately with Section 508 compliance across the IT and acquisition lifecycles for the OCIO Customer Engagement Office in support ...
Senior Associate Regulatory Analyst. Econometrica is looking to hire a part-time Senior Associate with Regulatory and Compliance Subject Matter Expertise within our fast-growing Data and Analytics Group. Other responsibilities will include managing and contributing to research projects, guiding juni...
Oversee project management tasks including tracking, monitoring, and reconciling event expenses against budgets, while alerting the Project Manager to potential risks or cost overruns. ...
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...
Provide Agency IT project managers with guidance on OCIO Program and Project Management policies and procedures related to project governance, milestones, key decision points, and system engineering reviews. Tracking each project plan and assisting with the prioritization of critical resources while...
Quality Assurance (QA) Specialist. We need an experienced Quality Assurance (QA) Specialist at the Naval Dosimetry Center (NDC). In this role, you assist command with your expert knowledge of quality management standards, accrediting agencies and regulatory requirements about laboratory operations, ...
HIAS seeks a Program Specialist, Quality Assurance & Training to coordinate data collection, cleaning and analysis in the Preferred Communities (PC) program and to provide the HIAS affiliate network with technical support as needed, in close collaboration with the Program Manager, Preferred Comm...
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...
Electrical Project Manager/Estimator Compensation & Benefits. Total compensation for the Electrical Project Manager/Estimator is between $80,000 and $125,000 depending on experience and maybe more than this range for candidates with exceptional experience and a successful history of performance....
Administrative Unit Program Manager. The Program Manager will be responsible for ensuring the Task Order team completes their work on time and within budget, as well as guiding the teams as needed. With experts in biomedical science, software engineering, and program management, we focus on developi...
Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the COVID-19 franchise to be based in one of Modernas US offices. The Associate Director will be a strategic leader within the Global Regulatory Strategy, Infectious Diseases group. As an expert w...
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...
Regulatory Affairs, Advertising and Promotion required; manager experience preferred. Monitor applicable current and new regulatory requirements within Advertising & Promotional practice area; provide regulatory environment updates to Commercial teams when needed. Advanced degree in pharmacy, re...
Associate Facilities Project Manager. Bachelor's degree in a related field and willingness to learn all aspects of project coordination; A minimum of 2-5 years' experience in facilities project coordination; or a combination of education and experience. Responsible for a wide range of facility engin...
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...
Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients.USP's fundamental belief that Equity = Excellence manifests in our c...
Ripple Effect is looking for a part-time, 508 Compliance Document Specialist with 2 years of professional, relevant experience to support our clients' missions. Provide Section 508 Compliance document accessibility reviews and document remediation in accordance with 508 standards and requirements&nb...