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...
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...
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 ...
The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). 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 w...
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...
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...
The Assistant Project Manager is responsible for assisting the Project Manager with planning, directing, and coordinating, daily construction management activities. Reviewing project budget and timeframe with the Project Manager, and ensuring a good understanding. Assist the Project Manager and Supe...
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 ...
N4 Solutions, LLC is seeking a Program Manager to support our customer the National Institute of Neurological Disorders and Stroke overseeing logistics management for virtual, hybrid, and in-person events of varying scales. The Program Manager is accountable for the end-to-end execution of large, in...
Extensive construction experience as a project manager or construction manager for a construction management firm, contractor, owner, developer, or designer. Capable of managing project managers, multiple teams, and multiple assignments, taking projects from conception to completion. Evidence of pro...
Track all program cost, schedules and performance against established program milestones; reporting the status to management stakeholders on a regular basis. Ensures program methodologies for the LOB and/or CO and the program management directives are followed. Understand and develop methodologies t...
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...
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...
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...
Manager Trainee- Operations (Travel Program- Relocation Required). The development program lasts approximately 12 months. Upon completion, you’ll have an additional six months to advance into an Assistant Manager position. During the program, you’ll learn the business and industry, and build your sk...
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...
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...
Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
The compliance analyst will work alongside a dedicated team of highly trained compliance professionals to ensure our projects meet their compliance objectives. The Compliance Analyst serves as the project compliance expert on a wide portfolio of Clarks government-funded construction projects. This i...
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...
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 compliance analyst will work alongside a dedicated team of highly trained compliance professionals to ensure our projects meet their compliance objectives. The Compliance Analyst serves as the project compliance expert on a wide portfolio of Clarks government-funded construction projects. This i...
Under general supervision from a Compliance Director, the Compliance Specialist monitors CNHS's adherence to regulatory requirements and organizational policies and procedures. Assist Compliance Directors and the Vice President of Compliance with developing and reporting compliance metrics, as neede...
Director Regulatory Affairs - Late Cardiovascular, Renal and Metabolism. In Regulatory Affairs, our teams influence the development of our innovative pipeline, define the regulatory strategy for our therapeutic assets, and engage with Health Authorities to effectively inform our development programs...