Coordinate and prepare regulatory submissions in collaboration with regulatory lead(s). Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs, work instructions, and templates. Stay abreast of regulatory guidance and changes in regulatory cli...
Regulatory Compliance Specialist - Clinical Trials. Maintains effective relationships with research staff, Principal Investigators, Institutional Review Board (IRB) regulatory personnel, SC2i consortium regulatory counterparts, and other key stakeholders to ensure the continued scientific and operat...
Coordinate and prepare regulatory submissions in collaboration with regulatory lead(s). Supports regulatory departmental activities as needed, including the authoring and reviewing of regulatory SOPs, work instructions, and templates. Stay abreast of regulatory guidance and changes in regulatory cli...
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 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...
Senior Associate Regulatory Analyst. Econometrica is looking to hire a 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 junior staff, ...
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 ...
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...
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...
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...
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 ...
Reviews identified issues to be pursued based on large, unusual or questionable items that produce a significant tax or compliance effect and utilizes the tax law and facts needed to resolve them. ...
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...
Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Director, Global Regulatory Affairs – RNA vaccines. Are you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape...
Do you have experience in all aspects of a Regulatory Affairs project, supporting technical/ CMC, clinical, nonclinical and procedural aspects of strategy and submissions, but are looking to take this to the next level, supporting a best in class vaccine as we expand into new markets and maintain cu...
Regulatory Affairs Manager - (MGRRA_COMPANY_1). Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure com...
Budget & Fiscal Compliance Specialist, North America. 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 i...
STIG Compliance Specialist to support the Army Research Laboratory (ARL). The STIG Compliance Specialist will work within the Cybersecurity Office under the Office of the Chief Information Officer (OCIO), ensuring that ARL systems meet baseline security requirements and comply with DISA STIG guidanc...
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...
FOIA Scientific Program Manager . ...
Program Specialist, Quality Assurance & Training. 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 ...