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...
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...
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 ...
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...
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...
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...
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...
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 requirement...
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...
The Global Programs Manager collaborates closely with Marketing, Business Development, Partners, Sales, and Enterprise Systems teams to execute Programs. Operationalize the program from start to finish, which includes managing the execution across multiple cross-functional teams, delivery, follow-up...
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...
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...
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...
Links Global is recruiting for health communications deputy program manager who will be responsible for planning, developing, implementing, and evaluating overall program policies and directing subordinate managers and staff. DutiesSupport the program manager in planning, devleoping, implementing an...
Duties Support the program manager in planning, developing, implementing and evaluating the program. Links Global is recruiting for a deputy program manager for a National Institutes of Health administrative support contract that is currently under development. Develop and update policies,...
Senior Law Enforcement Compliance (Sex Offender) Analyst. ...
Quality Assurance (QA) Specialist ROLE We need an experienced Quality Assurance (QA) Specialist at the Naval Dosimetry Center (NDC). Drills test the response of personnel and efficacy of processes during simulated unscheduled events and provide documented results to improve aspects of the dosimetry ...
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...