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 ...
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 ...
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 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 ...
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. ...
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...
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 ...
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...
The Regulatory Affairs Specialist is responsible for ensuring that the company aligns with all of the regulations and laws pertaining to our business; working with federal, state, and local regulatory agencies on specific issues affecting our business; and advises the company on the regulatory aspec...
The Federal Regulatory Affairs Manager directs US Federal regulatory package/dossier development, product registration, and lifecycle management of all Certis Biologicals products. The Regulatory Affairs team is responsible for obtaining and maintaining regulatory approvals for Certis Biologicals li...
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 ...
Soliant is seeking a qualified pharmacist with long-term care (LTC) experience to join our team in Columbia, MD. As a pharmacist with Soliant, you'll enjoy excellent support and flexible scheduling options. ...
You will work closely with the Government Program Manager and Technical Points of Contacts to help execute their program within the defined schedule and budget, work daily with customers to provide status, and insight into program execution. Successful completion of at least one (1) year as Task Ord...
Primary responsibilities of the Technical Writer are as follows:. Research highly technical subject matter, organizes information from multiples sources, and express technical information in written form that is comprehensible to a wide audience of readers. Apply concepts for technical writing based...
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...
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...
Project Managers are required to prepare project proposals and budgets, write technical project reports, prepare and maintain project budgets, perform project invoicing, review daily field reports prepared by field staff, perform peer reviews of deliverables prepared by other Project Managers, daily...
The Level 3 Quality Assurance Specialist shall possess the following capabilities:. We're searching for talented individuals who provide Quality Assurance support. Review and provide feedback to the Government on the documents and deliverables ensuring that quality assurance requirements adhere to t...
The Compliance Analyst role within the Housing Opportunities Commission of Montgomery County entails a comprehensive set of responsibilities critical to maintaining and enhancing the quality and compliance of our affordable housing operations. The Compliance Analyst is responsible for identifying an...
HIAS seeks a Program Specialist, Quality Assurance & Training to coordinate data collection, cleaning and analysis in the Preferred Communities (PC) program and to provide the HIAS affiliate network with technical support as needed, in close collaboration with the Program Manager, Preferred Comm...
The successful applicant will join ATR's Engineering Services Division, working as a member of the technical writing team. Edit draft manuscripts submitted by government engineers and scientists to ensure proper grammar, usage, and consistency and clarity in the presentation of the technical con...
Tech Solution Inc is hiring Technical Writer at Baltimore, MD. A minimum of 5-7 years of experience as a writer on technical proposals. Write proposal content, including technical sections, management and staffing sections, resumes, and executive summaries. Bachelor's degree in a relevant topica...
Collaborate with collection architecture developers, signals analysts, network analysts, computer scientists, and external agencies to acquire, maintain and maximize access to global communications. The role of Analyst includes Identify policies and authorizations necessary to provide compliant targ...
Strategic Ventures Consulting Group (SVCG), LLC is a technical and management consulting company that provides services that solve government and commercial clients’ most difficult problems. Provide technical edits to engineering documentation, software documentation, manuals, reports, or any ...