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...
Prepare, review, and submit high-quality regulatory documents, ensuring accuracy and compliance with global regulatory requirements. Ensure compliance with regulatory commitments and maintain up-to-date regulatory documentation and databases. Minimum of 8 years of experience in regulatory affairs, w...
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...
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...
Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Associate Regulatory Affairs Director. Contribute to regulatory submission strategy, identifying submission risks and opportun...
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 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...
MBP has exciting opportunities for project managers with experience in the design and construction of complex facilities that have a high degree of creativity, foresight, and mature judgment in anticipating and solving design and construction problems, determining program objectives and requirements...
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...
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 ...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
Collaborate with collection architecture developers, signals analysts, network analysts, computer scientists, and external agencies to acquire, maintain and maximize access to global communications. The role of Analyst includes Identify policies and authorizations necessary to provide compliant targ...
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...
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...
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...
As our EWOKS TO Deputy Program Manager, you will be providing programmatic leadership and management to our Team Leads who operate in Bethesda, MD; Reston, VA; Patrick Space Force Base, FL; and coordinate/collaborate with OSINT SMEs throughout the DoD and IC. The DIA/OSIC Program consists of four ma...
Leidos has an exciting opportunity for a Project Manager with data science and system engineering experience supporting the National Media Exploitation Center (NMEC) under our 10-year DOMEX Technology Platform (DTP) contract. As the Project Manager, you will support a team that is delivering cutting...
If so, we 're looking for someone like you to join our team! We are seeking a Compartment Security Compliance Project Analyst (CSCPA) to help provide APL and its sponsors with the highest level of security support. Compartment Security Compliance Project Analyst (CSCPA). Provide security guidance re...
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...
About the Information Security Compliance Specialist position. As an Information Security Compliance Specialist, you will be expected to document security control implementations, maintain a variety of security documents, and monitor the effectiveness of the overall security program. Informatio...
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 ...
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...
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...