Regulatory Affairs Specialist: Average Salary in Silver Spring, MD in 2024

Ensures that protocol and regulatory documents are maintained and are kept up to date. Maintains study compliance with established local, state, federal, and DoD regulations for human subjects' research with institutional regulatory direction from USUHS, WRNMMC, and HJF. Maintains complete and accur...

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 Regulatory Compliance Specialist is a critical member of the Regulatory and Laboratory Compliance team of Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD. The Regulatory Compliance Specialist ...

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 ...

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...

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 ...

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...

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...

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...

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...

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...

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...

You'll be joining a hardworking team of program managers and engineers who are responsible for generating impactful work in the cyber and intelligence domains! We strive to foster an environment of innovation through the application of science and technology to operational challenges. As the Cyber T...

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...

The Project Manager is responsible for managing project scope for a large-scale event, with possible support from Associate Project Managers. The Project Manager will report to the Associate Director, Project Management. The Project Manager will ensure successful and profitable execution of events b...

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...

Lead Government Accounting Analyst. Accounting & Government Compliance organization. This position will report directly to the Director of Government Accounting & Compliance. It will support government accounting and compliance activities such as developing and submitting direct and indirect rate pr...

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...

Demonstrated ability to progress a packaging project from inception to commercialization including packaging materials, designs and manufacturing processes, qualification, validation and systems. ...

The ideal candidate will oversee complex projects in. Responsible for scope, schedule, budget, and safety, with projects typically ranging up to $75 million. Responsible for delivering projects on time and within budget. ...

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 & Regulato...

The Senior Manager, CMC Facilities Regulatory Affairs will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects. Management of facilities and equipment matters required for INDs, registration a...

The Senior Project Manager will be based on the construction project site and will be responsible for taking projects from conceptual stages through closeout. At Clayco, a Senior Project Manager is responsible for assisting with preconstruction, buying out contracts, and managing the project from st...

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 Analyst will play a pivotal role ensuring compliance with federal funding while supporting various components of the Compliance team. Climate United Fund, a 501(c)(3) nonprofit (“Climate United”), is seeking a full-time Compliance Analyst for an entry level position to support adherence to regul...