Regulatory Operations Associate. Prepare standard documentation supporting regulatory filings and distribution to stakeholders. Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. Track regulatory activity, maintain and update databases, and ensure that r...
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...
Associate Regulatory Affairs Director. 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. Contribute to regulatory submission strategy, identifying submission risks and opportun...
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...
Associate Regulatory Affairs Director. 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. Contribute to regulatory submission strategy, identifying submission risks and opportun...
Quality/Risk Management US Regulatory Affairs. The Food and Drug Administration (FDA) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
I am seeking an experienced associate-level attorney to join a great firm with a federal grants practice group, as well as to support the litigation team. ...
I am seeking an experienced associate-level attorney to join a great firm with a federal grants practice group, as well as to support the litigation team. ...
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...
We are seeking a Senior Level Regulatory and Legislative Specialist in Rockville, MD. The Senior Level Regulatory and Legislative Specialist will leverage extensive experience in developing and managing Federal programs related to the U. The specialist will play a pivotal role in creating and implem...
Assist in advising clients on compliance with federal and state laws, rules, and regulations. Help create and maintain essential compliance tools for clients and internal teams. Develop and maintain compliance resources for clients and internal staff, drawing on your understanding of relevant regula...
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...
The Project Manager position is a highly visible strategic position to ensure exceptional project management in delivery of network services to NIH. Manage project status using ServiceNow Project Portfolio Manager. Leidos Health Mission Solutions is seeking a Senior Project Manager,. Provide overall...
Performance Management Data Analyst ) who will be responsible for the compliance monitoring of the retirement benefit process of the Montgomery County Employee Retirement Plans. Overseeing the third party recordkeeper, related to corrections of employee accounts, outside agency contribution reconcil...
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, regula...
Senior Regulatory Program Manager (GS 13/14) role. The ideal candidate will have a broad understanding of clinical research, regulatory and policy requirements especially NIH, OHRP, and FDA requirements. ...
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, regula...
The Senior Analyst, Global Trade Compliance ("Senior Analyst") is a key member on the Global Trade Compliance team at ESAB and will report to the VP, Global Trade Compliance. Senior Trade Compliance Analyst will show history of implementing trade compliance systems (from screening tools to...
Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy. Senior Director, Global Regulatory Affairs Development Pipeline, Cell Therapy . Define the strategy for regulatory interactions, lead regulatory meetings with national authorities and sovra-national agencies (e. Define a...
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. Senior Manager, Public Policy, International Government and Regulatory Affairs (IGRA)- Hybrid Rockville , Maryland...
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...
The Senior STIG Compliance Specialist plays a key role in enhancing the organization’s security posture and ensuring ongoing compliance with federal regulations. Lead and mentor junior compliance specialists and IT staff on STIG compliance best practices and procedures. Minimum of 8+ years of experi...
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...
As a Senior Project/Program Manager, you will lead all aspects of, drive and approve plans for projects/programs, manage and coordinate project/program budgets, forecasts, tasks, schedules, risks, change management, and status. Join our dynamic IT team as a Senior Project/Program Manager, where you ...