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. ...
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...
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 ...
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 ...
Reinforce the PointClickCare Implementation project manager as the project leader, and provide support to the project through product enhancement escalations and discussions. Reporting to the Manager of Professional Services, you will act as the primary client liaison to lead multiple customer facin...
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...
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...
In addition to highlighting trade compliance requirements through meetings, the Program Trade Licensing and Compliance Lead will be required to gain an understanding of the various technologies supported by the mission area to assist with domestic and international trade compliance needs. We are see...
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...
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 Office of Grant Performance and Compliance oversees activities that ensure compliance with policies and regulations as it relates to participants’ eligibility. Also, compliance and performance issues are audited, evaluated, and resolved. Audit data regularly to ensure compliance with data ...
As the Program Management Trade Licensing and Compliance Lead, you will help guide the mission areas by managing and assessing classification and jurisdiction and specially designed aspects of program hardware, software, technical data, and services enumerated under the ITAR, EAR, and Customs Regula...
Will work closely with the Director of Compliance in preparing and implementing policies and procedures. Monitor compliance with policies and procedures. Train communities on compliance procedures. ...
Budget & Fiscal Compliance Specialist, U. HIAS seeks a Budget & Fiscal Compliance Specialist, U. Budget & Fiscal Compliance. Manages reporting, compliance and recognition of U. ...
As the Deputy Super Office Director for Operations, the incumbent will oversee offices within OND that manage the regulatory, business process, and administrative operations, providing leadership and supervision on developing and implementing relevant processes and procedures, and assuring that key ...
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...
Manager / Senior Manager, Compliance & Reporting Specialist. KPMG is currently seeking a Manager / Senior Manager to join our Global Compliance Management Services practice. Collaborate with and guide internal teams and clients through transition and execution of corporate compliance engagements, in...
Responsibilities - Perform site development engineering and project management tasks for residential and commercial projects - Projects will include a variety of land development site designs - In addition to strong technical experience, other responsibilities will include research, coordination, pr...
Research provider/subscriber claims activity, operations manuals, data systems, medical policies, job duties and group benefit contracts to identify control deficiencies and non-compliance. ...
The Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position involves interpreting ...
We are now looking for a Safety & Compliance Specialist, Logistics Operations for our Supply Chain Management function within the industry and water segment. Support the Safety Manager in maintaining compliance with transportation operating authority, licenses, permits, credentials, and regulatory p...
Located in Germantown, MD Project Enhancement Corporation (PEC) is a technical services business focused on providing Project Management and specialized consulting services in the areas of emergency operations, nuclear incident response, nuclear safe Program Manager, Senior, Program, Manager, Techno...
Overseeing program execution and client success, the program manager develops the plans and timelines for program deliverables, performance metrics, trend analysis, and identifies opportunities to improve efficiency, effectiveness, and experience. Federal Programs/Program Manager (Hybrid/Remote) 202...
Procuremet/Compliance Specialist monitors and resolves compliance issues, mitigates contractual risk, maintains materials and procedures, and provides support to management. Audits procurements conducted within agency delegated authority, purchasing card utilization, and compliance monitoring with t...