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, regula...
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...
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 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...
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 & Regulato...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Federal Regulatory Affairs Manager will collaborate closely with the North America Team Leader and business-lead Vi...
The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration 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...
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...
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...
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 Project Manager, CMC Regulatory Affairs will be responsible for the CMC regulatory activities in the investigational, late phase development and/or early commercial lifecycle management of GSK products. Two or more years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory aff...
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...
Responsible for providing services to the Compliance Group to ensure the corporation's compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Use compliance-related tools to audit, monitor, or gather oversight and compliance data. Coordinate compli...
Public Health Informatics and Technology Program Manager. The Program Manager provides critical day-to-day support to the PI of a grant and comprehensive knowledge and application of institutional policies and procedures in relation to the grant project; works closely with the PI to ensure effective...
Global Project Manager (SGPM) is critical to the successful conduct of Biopharmaceutical-sponsored clinical trials as a matrix leader of the core project team. The SGPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project...
Strong leadership and managerial skills. ...
Logistics Professional with at least 5 years of experience as a Medical Supply Logistician and Supply Chain Manager with demonstrated strengths that include not limited too; assessing organizational needs, setting strategic direction, and implementing initiatives that enhance performance. ...
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...
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...
We are seeking a highly skilled Senior Sales Project Manager for our client, a leader in the HVAC/Mechanical industry. Project Documentation: Organize and maintain accurate project documentation for efficient reference and management. You will work closely with various internal teams to ensure proje...
As an Information System Security Manager. Your main responsibility will be to ensure classified systems follow government and APL regulations while still meeting program demands and operating in an accredited state. You will support the Chief Information Security Officer (CISO) and the Chief of Cla...
Coordinating the efforts of several Project Managers, either on one mammoth project, or for large numbers of projects. Directs and coordinates all resources for all task orders, including subordinate Project Manager staff and other staff resources. Project Management Professional (PMP) certification...
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...