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...
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...
Five (5) years of global regulatory affairs experience within the pharmaceutical industry in the job offered, as a Regulatory Affairs Specialist, or in a related occupation. Associate Regulatory Affairs Director. Contribute to regulatory submission strategy, identifying submission risks and opportun...
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...
Prepare, review, and submit high-quality regulatory documents, ensuring accuracy and compliance with global regulatory requirements. Ensure compliance with regulatory commitments and maintain up-to-date regulatory documentation and databases. Minimum of 8 years of experience in regulatory affairs, w...
The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). 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 w...
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 ...
Experience in clinical regulatory affairs as well as CMC regulatory affairs for pre-licensed and licensed biologic product or vaccine. Understand the constraints and drivers of other functions and the potential impact on regulatory affairs World-wide, including how regulatory affairs may facilitate ...
The Assistant Project Manager is responsible for assisting the Project Manager with planning, directing, and coordinating, daily construction management activities. Reviewing project budget and timeframe with the Project Manager, and ensuring a good understanding. Assist the Project Manager and Supe...
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...
The incumbent will serve as an inter-agency consultant on compliance related matters. This person will review to ensure compliance of Davis Bacon certified payrolls and customer Reasonable Accommodation requests. Will manage and monitor compliance reporting, investigate, follow-up and follow through...
Senior Associate Regulatory Analyst. Econometrica is looking to hire a Senior Associate with Regulatory and Compliance Subject Matter Expertise within our fast-growing Data and Analytics Group. Other responsibilities will include managing and contributing to research projects, guiding junior staff, ...
We are seeking a Section 508 Compliance Analyst to provide support in managing, consulting and ensuring information and communication technology activities integrate appropriately with Section 508 compliance across the IT and acquisition lifecycles for the OCIO Customer Engagement Office in support ...
Ripple Effect is looking for a part-time, 508 Compliance Document Specialist with 2 years of professional, relevant experience to support our clients' missions. Provide Section 508 Compliance document accessibility reviews and document remediation in accordance with 508 standards and requirement...
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...
Prepares other Scientific and Regulatory documents for submission to Regulatory Authorities including pre-IND Meeting Requests and Packages, Orphan Drug Designation requests, Priority Review requests, Fast Track requests, etc. Experience in preparing regulatory documents, publishing regulatory submi...
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 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 & Regulatory A...
HIAS seeks a Budget & Fiscal Compliance Specialist, North America to support our North America Programs in the creation and management of budgets, as well as the management of grants and cooperative agreements from initiation to closure in the United States and overseas. Manages reporting, complianc...
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...
BAE Systems is seeking an analyst to join the Government Compliance team within the Finance organization. Joining our team means you will work independently and as a team applying your strong working knowledge of government contract accounting practices and regulations to ensure accurate reporting a...
The Senior STIG Compliance Specialist plays a key role in enhancing the organization’s security posture and ensuring ongoing compliance with federal regulations. Lead and mentor junior compliance specialists and IT staff on STIG compliance best practices and procedures. Minimum of 8+ years of experi...
Audio Visual Program Manager – Rockville, MD. Their Digital Innovation Team is looking for a skilled Program Manager with experience in A/V systems to oversee and deliver a growing portfolio of projects. Plan, schedule, and oversee engineering, programming, fabrication, installation, and subcontract...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
Develop program roadmap to execute requirements for 20+ projects. ...