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...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams for assigned projects negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions. ...
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...
Coordinate the day-to-day administrative activities of the clinical research trials program, including mentoring Research Regulatory Specialists with a focus on study activation. Lead a team of Research Regulatory Specialists and/pr Coordinators. Prepare and/or provide guidance to Regulatory Special...
Global Trade Compliance Specialist. Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper pro...
Direct multiple complex and high-priority special assignments involving extensive research, fact-finding, and analysis on a variety of high-level IT subjects ofcritical importance to CMS, CCSQ programs. Experience refers to paid and unpaid experience, including volunteer work done through National S...
Under supervision of the Director of Population Health, the Clinical Program Manager provides leadership of all programmatic, personnel, and operational activities for specified programs implemented within the Population Health Department. The Clinical Program Manager will design, implement, monitor...
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 ...
The Senior Project Manager of Strategy and Compliance leads the work within departments of the Office of the Chief Operating Officer regarding strategy implementation and alignment, performance monitoring and evaluation, policy development, and effective operating processes. Plans, directs, monitors...
Corporate Governance - Analyst, Regulatory Compliance. Research provider/subscriber claims activity, operations manuals, data systems, medical policies, job duties and group benefit contracts to identify control deficiencies and non-compliance. ...
We are seeking a Technical Project Manager to support the Information Analysis Center Multiple Award Contract (IAC MAC) and Task Order (TO). Responsible for successful delivery of a program to a customer; or manage performance of a task or project as part of a larger program under direction of anoth...
The Program Manager IV will oversee all activities related to supporting the CDES PMO, specifically in the following areas: program management, assessment and authorization, requirement analysis, customer management, project management, lab support, production support, enterprise architecture, deplo...
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 ...
Compliance Education Specialist. Office of Compliance Professional Fee Services Compliance Plan. Oversees compliance education activities in accordance with the Professional-Fee Services Compliance Plan. Serves as Lead for compliance training and prepares and/or reviews all billing compliance traini...
Global Trade Compliance Specialist. This position focuses on implementing international trade compliance activities into daily business operations, conducting compliance assessments, and working with a variety of internal stakeholders to ensure that the proper processes, procedures, and authorizatio...
Under general supervision works closely with key stakeholders to implement elements of the Corporate Privacy Compliance Program to ensure compliance with existing and new federal and state laws and regulations affecting the University of Maryland Medical System (UMMS). Sits on UMMS and Member Organi...
Regulatory Affairs Specialist, Medical Device. Handling the regulatory assignments with a good understanding of medical process standards ISO13485, ISO14971, IEC 62304, and IEC 62366. Regulatory strategy preparation. Regulatory assessment for the Electro-mechanical devices. ...
This opportunity entails being responsible for managing assigned project(s) throughout their full lifecycle including developing the scope and technical sections of proposal and procurement documents to participating in contract negotiations and overseeing the delivery of the project plan to success...
The Assistant Project Manager (APM) will assist project managers on a variety of projects of varying complexity, and/or will manage some smaller and less complex projects on their own. Verify Contractor compliance including quality, safety, environmental, and material management programs. Adhere to ...
Provide services to the Compliance Group to ensure compliance with relevant laws, executive orders, directions, and regulations governing mission activities. Coordinate compliance training and initiate changes in procedures due to new or revised regulations. Produce documentation related to complian...
As a Manager, Compliance you will be responsible for oversight and implementation of compliance initiatives. Advise and consult on matters related to compliance with laws, regulations, applicable company policies, ethical behavior, and compliance trends. This role is responsible for assisting in the...
Under the supervision of the Director of Compliance for Education, Training, & Regulatory Monitoring, the analyst will assist with the management, development, implementation and monitoring processes to ensure compliance with federal and state laws and regulations affecting the University of Marylan...
With excellent stewardship from our divisions, we oversee State and federal programs that support the needs of a diverse population – students, teachers, principals, and other educators throughout Maryland. TheCoordinator of Blueprint Implementation and Strategic Initiatives isresponsible for coordi...