Regulatory Science Reviewer: Impactful FDA Submissions
U.S.-Food-and-Drug-Administratio
The U.S. Food and Drug Administration seeks a Regulatory Scientific Reviewer (AD-0696-00) under Title 21 authority. The position requires a qualifying degree or equivalent experience and may require transcripts to prove education. A master’s or doctorate can substitute for experience as outlined. Typical candidates have regulatory affairs or public health experience, focusing on consumer safety and compliance with FDA standards. #J-18808-Ljbffr U.S.-Food-and-Drug-Administratio
$185k - $225k
...Health for Translational Sciences to evaluate, establish... ...science, and regulatory engagementworking with... ...with agencies (e.g., FDA, EMA) Ensure study... ...contribute to regulatory submissions, qualification packages... ...Track record of high-impact publications and scientific...RegulatoryFull time- ...equivalent). In order to qualify for the Regulatory Scientific Reviewer (Regulatory Specialist) position... ...: consumer laws, biological sciences, food science, chemistry, pharmacy,... ...policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing...Regulatory
$18 per hour
MPF Federal is hiring a Records Management Specialist 1 (general clerk) to support the FDA's regulatory mission by keeping critical documents organized and accessible. This on-site/hybrid role in College Park, MD offers structured processes and close supervision to build...RegulatoryHourly pay- ...The role involves conducting reviews of environmental assessment documents to identify impacts on environmental justice communities... ...of the Federal Energy Regulatory Commission's Equity Action Plan... ...Doctorate degree in Environmental Science and proficiency in Microsoft...RegulatoryFull timeWork at office
- FDA in the United States seeks a Regulatory Scientist to enforce and ensure compliance with FDA laws and regulations, interpret statutes, regulations, guidance, and quality policies to assess compliance, quality, manufacturing performance, or quality management maturity...Regulatory
- ...Help Complete preliminary clinical reviews, assignments and projects related to regulated... ...that have a national or international impact on health. Review the safeguards for testing... ...cutting edge expertise of the "state of science" to incorporate the most advance theories...Regulatory
- Liberty Healthcare Corporation in Maryland is hiring multiple full-time Quality Reviewer positions to support person-centered service delivery and CMS regulatory compliance. This field-based role requires extensive regional travel (70-80%) to residential and day service...RegulatoryFull time
- ...Job Title Job Description Performs comprehensive clinical and scientific evaluations of a broad range of regulatory submissions, INDs, IDEs, BLAs, PMAs, and 510(k)s, assessing clinical trial design, safety, efficacy, and benefit-risk to support regulatory decision...Regulatory
- ...help make a lasting impact on the lives of... ..., innovative, and science‑based. If you have... ...transforming your career. Regulatory Affairs Senior... ...the creation and submission of regulatory... ...agency communications Review US component of... ...submissions to the US FDA Assist the Global...RegulatoryFlexible hours
- ...Medical Science Liaison, Camzyos The MSL role embodies our medical... ...medical insights and/or impact by communicating these back to... ...stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal,... ...GDO Support HCPs in the ISR submission and execution process and study...RegulatoryLocal areaRemote workHome office
- ...Amgen SA is seeking a Regulatory Affairs Senior Associate in Washington, DC, to assist in creating and submitting regulatory documents.... ...role includes managing documentation, ensuring compliance with US FDA regulations, and participating in Global Regulatory Teams. The...Regulatory
$95 - $96 per hour
...Be Doing: Serve as the Physician match reviewer in Imaging cases, that do not initially... ...providers, when available, within the regulatory timeframe of the request and provides clinical... ...identity verification steps, including submission of a government issued photo ID. We...RegulatoryFull timePart timeWork at officeImmediate start$36.42 per hour
...health protection and regulatory compliance. In this role... ...and associated client submissions to enable traceable... ...actions, and associated impacts to production are... ...to support management review and quality compliance... ...'s degree in physical sciences or a closely related discipline...RegulatoryHourly payFull timeContract workWork at officeWorldwide- ...Medical Science Liaison, Camzyos The MSL role embodies our medical... ...medical insights and/or impact by communicating these back to... ...stakeholders (e.g. Commercial, Regulatory, Pharmacovigilance, Legal,... ...GDO Support HCPs in the ISR submission and execution process and study...RegulatoryLive inLocal areaRemote workHome office
- ...Description Prepares scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) (Investigational New Drug... ...analyze medical research data and review experimental protocols. Meets expectations...RegulatoryWork at officeRemote work
- ...Qualifications To qualify for the Regulatory Scientist position (0696... .../management, data science, statistics, computer... ...experience or FDA‑regulated product lifecycle... ...experience conducting scientific review and evaluation of regulatory submissions and performing analyses...Regulatory
$50k - $80k
...in Bethesda, MD . Responsibilities Review and process essential regulatory documents received from clinical trial... ...or database Ensure documents meet FDA, ICH GCP, and sponsor requirements... ...systems Experience with IRB submissions and OHRP regulations is a plus Bachelor...RegulatoryWork at office- The American Association for Cancer Research is seeking a Director, Regulatory Science and Policy to lead initiatives impacting cancer research policy. You will work closely with the VP of Science Policy and Government Affairs to advance regulatory science efforts and benefit...Regulatory
$75.04k - $112.56k
...support to meet both internal and external regulatory expectations. Work Schedule and... ...evaluate organizational and operational impacts, and clearly communicate required compliance... ...-of-interest program, including the review of submissions and comprehensive reporting within the...RegulatoryFull timeWork at officeLocal areaRemote workFlexible hours- ...looking to make a meaningful impact in clinical development?... ...statistical analyses, support regulatory submissions, and influence critical... ...the GBDS (Global Biometric Sciences) Biostatistics Lead, medical... ...leaders. Authors and/or reviews protocol synopsis, protocol...RegulatoryRemote workFlexible hours
- ...Yorktown Systems Group is hiring a German Reviewer/Editor/Certifier to provide vital language assistance for the Department of Justice... ..., interpretation, and transcription services for legal and regulatory documents, demanding five years of past experience and strong...RegulatoryPart time
- ...international activities, working within FDA and with other U.S. government agencies,... ...Identifying policy issues for current and future impact on HFP and conducts analysis of their... ...; AND Analyzing international policy or regulatory issues and recommending an appropriate...RegulatoryWork experience placementSecond jobWork at officeRemote workRelocation package
$127k - $156k
FDA Regulatory Managing Scientist We are currently seeking an FDA Regulatory Scientist for... ...strategy development, application submission, and review process for new and generic drugs Manage... ...Master's or Ph.D. degree in a science-related field Five (5) or more years...Regulatory- ...forest resources through science, education, and... ...engagement, revenue, program impact) Analyze... ...state filings Oversee submission of required reports and... ...support staff in contract review and compliance Lead organizational... ...best practices and regulatory changes Willingness to...RegulatoryContract workTemporary workWork at officeLocal areaRemote work
- ...compliance, accurate payroll tax submissions, and year-end balancing... ...and regulations. Assess the impact of tax law changes on employee... ...of quarterly documentation reviews. Perform special payroll tax... ...compliance and associated regulatory requirements. ~ Knowledge of...RegulatoryLocal areaRemote work
- ...Drug Administration (FDA) Duty Description:... ...World Evidence to Support Regulatory Decision-Making for... ...aspects of regulatory submissions. These analyses should... ...50, and Institutional Review Boards under 21 CFR 5.... ...Advanced degree in life sciences, or other area...RegulatoryFull timeFor contractorsWork at officeRemote work
$54.5k - $80k
...Control Specialist will perform operational duties in support of regulatory, security, and industry practice compliance requirements. This... ...security, and industry practice documentation. Coordinate the review, verification, and approval of document updates and revisions....RegulatoryHourly payFull timeWork at officeLocal areaRemote workWorldwide- ...project teams, the Legal Department, clients, contractors, and regulatory agencies. The Project Document Control Manager maintains... ...accurate, secure, and easily accessible. Coordinate document reviews, approvals, and distribution with project managers, engineers,...RegulatoryContract workFor contractorsFor subcontractorWork at officeLocal area
- ...Physical Medicine & Rehabilitation physician to process utilization reviews. Work's Compensation experience is preferred but not required.... ...and responding to quality assurance issues, complaints, regulatory issues, depositions, court appearances, or audits....RegulatoryFor contractorsRemote workMonday to Friday
$140k - $160k
...licensing and compliance and FDA regulatory matters, with... ...FDA regulatory matters impacting pharmacy and... ...market surveillance. Review agreements related to... ...Bachelor’s degree in Life Sciences, Pharmacy, Chemistry,... ...Experience with FDA submissions, licensing requirements...RegulatoryWork at office
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