The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
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 ...
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 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 ...
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...
Are you a skilled Regulatory Affairs professional with a passion for strategic impact? This is an incredible opportunity to step into a dynamic environment where your expertise will shape regulatory strategies and submissions for groundbreaking therapies in clinical development. As Director of Regul...
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 ...
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. ...
Assist in the refinement and enforcement of Regulatory policies with particular emphasis on compliance to the company's Quality System, external regulatory standards (e. Canada pharmaceutical or medical device Regulatory Affairs. The Manager, Regulatory Affairs will provide support to Operations...
Director of Global Regulatory Affairs - Permanent - Maryland, US. Proclinical is seeking a Director of Global Regulatory Affairs, Development Strategy to lead the U. Director of Global Regulatory Affairs' responsibilities will be:. In this key role, the successful candidate develop and implement reg...
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. ...
The Senior Regulatory Compliance Analyst will conduct independent analysis for complicated, high level regulatory inquiries and provide interpretation of regulatory rules and guidelines to demonstrate compliance with state and federal requirements. Frequent interaction with all internal areas especi...
The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. Utilizes knowledge of regul...
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 Mar...
Develops Compliance Hotline statistical data for reporting to the Audit and Compliance Committee of the Board of Directors, the Executive Compliance Committee, the Affiliate Compliance Officer Committees and other meetings as requested. Works collaboratively with the Compliance Director in compiling...
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...
Translates a wide variety of customer needs/requirements requiring originality and ingenuity into detailed proposals and project plans to meet Customer requirements; reviews and approves estimated costs prior to bid; provision of technical assistance to sales force as and when required; project desi...
Create code documentation for software; produces implementation guides and end-user guides for capabilities; provides field, data definition, and data flow documentation and formats technical publications from pamphlets, technical drawings, and consultations with technical personnel and other availa...
Leidos has an exciting opportunity for a Communications and Technical Writer to support our customer. The role is primarily focused on internal IT related communications and technical writing, bringing clear information, direction, and resources, focused on technical information, products, processes...
CRC seeks qualified Tech Writers in Fort Meade, MD. Provide technical edits to engineering documentation, software documentation, manuals, reports, or any documents or presentations. ...
As a Technical Writer you will be responsible for the preparation, review, revision, and maintenance of technical documents including software and systems engineering, system operations, testing, and user documentation. Creates code documentation for software; produces implementation guides and end-...
Your role as Project Manager will lead the delivery and project management of electrical transmission routing and substation siting projects for investor-owned utilities and independent transmission developers. Project Manager/Environmental Planner - Routing & Siting - ( 240002R0 ). In this role...
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...
Communication:Regularly reviews cost and Key Performance Indicator metrics invoices process/policy communications to client partnersProvide project single point of contact for project development and deliveryCoordinate meetings and activities of vendors cost managers and integration of lessons learn...
Work with the Program Manager, Project Managers and Program Operations Coordinator to assess solicitation requirements, assist in the development and review of Statements of Work (SOWs), identify resource requirements (labor, materials, travel, subcontracts, etc. Work with the Program Manager and Pr...