Regulatory Affairs Jobs in Maryland

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Regulatory Affairs Manager

LMI Government Consulting (Logistics Management In

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Frederick, Maryland, USA

Contract

Overview LMI is seeking an experienced Regulatory Affairs Manager to support the Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO) at Ft. Detrick in Frederick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. This position can be performed hybrid/remotely with onsite requirements 1 day per week. This position requires the ability to pass a T1/NACI securit
Posted 60+ days ago | Updated moments ago

Regulatory Affairs Specialist- 100% remote in FL

ConsultNet, LLC

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Remote or Florida, USA

Full-time

Regulatory Affairs Specialist 100% Remote from anywhere in Florida 6+ month contract to hire $38.50- $52.00 an hour ($80k- $110k salary upon conversion) Immediate hire with growing company. The Regulatory Affairs Specialist will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presente
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Posted 22 days ago | Updated 3 hours ago

Data Risk Appetite Sr Group Manager, Director

Citi

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Remote or New York, New York, USA

Full-time

The Data Risk Appetite Sr Group Manager, Director is a senior level role managing a team responsible for facilitating all aspects of the Enterprise Data Risk and Control Framework and Data Risk Taxonomy. This role is responsible for Quarterly : Top Risk Alignment : Data Risk metricsRisk Appetite AssessmentScenario Analysis and Lessons LearnedData Risk ProfileMetric Adequacy AssessmentRisk Appetite analyticsMetric Maturity AssessmentMetric Coverage of the categoryIssues : thematic analysisLosses
Posted 8 days ago | Updated 4 hours ago

Principal Regulatory Consultant Dietary Supplements

Apptad Inc

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New Jersey, USA

Third Party, Contract

Job Description: Job Title: Principal Regulatory Consultant Dietary Supplements (U.S.-Based) Position Type: Contract / Consulting Location: Jersey City, NJ Department: Regulatory Affairs / Corporate Development Position Summary: We are seeking a highly experienced and credentialed Regulatory Consultant to support strategic M&A due diligence initiatives within the dietary supplement industry. This role demands deep understanding of the U.S. regulatory landscape, including DSHEA, FDA cGMPs (21 CFR
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Posted 9 days ago

Engineer III, Validation

Thermo Fisher Scientific

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Remote or Fair Lawn, New Jersey, USA

Full-time

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description When you're part of Thermo Fisher Scientific, you'll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the
Posted 57 days ago | Updated 4 hours ago

Associate Director - Hematology, Oncology Data Sciences & Digital Health

Johnson & Johnson

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Remote or New Brunswick, New Jersey, USA

Full-time

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn m
Posted 33 days ago | Updated 4 hours ago

Senior Manager, Data Analytics

Quest Diagnostics Inc.

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Remote or Wood Dale, Illinois, USA

Full-time

Overview Reporting to the Director, Program Management QA/RA, the Sr. Manager, Data Analytics - Quality & Regulatory Affairs will lead the development, management, and execution of a best-in-class analytics strategy in support of the QA/RA function. This position is responsible for establishing on-going processes for collecting and transforming data into strategic insights that support risk management, regulatory compliance, operational excellence, and governance reporting. This is a highly vi
Posted 19 days ago | Updated 1 day ago

Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

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Remote or Buffalo, New York, USA

Full-time

Overview: Leads risk analysis for complex initiatives, influencing overarching risk framework and providing advanced guidance to leadership for informed decision-making aligned with organizational imperatives. Primary Responsibilities: Develop and implement strategic approaches for in-depth risk assessments for comprehensive coverage of all technology capabilities.Develop and execute sophisticated risk management framework and programs that informs how to align practices with business objective
Posted 58 days ago | Updated 4 hours ago

Data Manager MedRA Coder (WHODrug)

General Dynamics

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Frederick, Maryland, USA

Full-time

Type of Requisition: Pipeline Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACI (T1) Job Family: Medical Affairs Job Qualifications: Skills: Clinical Data Management, Electronic Data Capture (EDC), MedDRA Coding, WHODrug Certifications: None Experience: 5 + years of related experience ship Required: Yes Job Description: GDIT's Military Health team is hiring Data Manager MedRA Coder (WHODrug) to support the Office of
Posted 12 days ago | Updated 4 hours ago

Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and Lifesciences

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Remote or New Jersey, USA

Full-time

Responsibilities: Lead validation planning, risk assessment, and execution for R Studio, GitLab, and Medidata Rave EDC. Develop and execute validation documentation including: Validation Plans (VP.). User Requirements Specifications (URS.). Risk Assessments (RA.). Functional and Design Specifications. Traceability Matrix (RTM.). Test Protocols (IQ/OQ/PQ or CSA-based scripts.). Validation Summary Reports (VSR.). Collaborate with cross-functional stakeholders including Clinical Data Mana
Posted 60+ days ago | Updated 4 hours ago

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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Remote or Foster City, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 11 days ago | Updated 4 hours ago

Senior Principal Systems Safety Engineer (Hybrid)

RTX Corporation

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Remote or Cedar Rapids, Iowa, USA

Full-time

Date Posted: 2025-05-12 Country: United States of America Location: HIA32: Cedar Rapids, IA 400 Collins Rd NE , Cedar Rapids, IA, 52498-0505 USA Position Role Type: Hybrid U.S. Citizen, U.S. Person, or Immigration Status Requirements: The ability to obtain and maintain a U.S. government issued security clearance is required.Security Clearance: DoD Clearance: Secret Collins Aerospace is seeking an experienced System Safety Engineer within our Missions Systems organization. This engineer will b
Posted 60+ days ago | Updated 4 hours ago

PKI (Public Key Infrastructure) Specialist

Cymertek Corporation

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Annapolis, Maryland, USA

Full-time

PKI (Public Key Infrastructure) Specialist LOCATION Annapolis Junction, MD 20701 CLEARANCE TS/SCI Full Poly (Please note this position requires full U.S. Citizenship) KEY SUMMARY We are seeking a skilled and detail-oriented PKI (Public Key Infrastructure) Specialist to manage and enhance our organization's certificate and encryption infrastructure. In this role, you will design, implement, and maintain PKI systems to ensure secure authentication, data integrity, and encryption across all platf
Posted 60+ days ago | Updated 4 hours ago

Senior Engineer, Design Transfer Specialist

Amgen Inc

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Remote or Cambridge, Massachusetts, USA

Full-time

Career Category Operations Job Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each
Posted 60+ days ago | Updated 4 hours ago

Sr. Manager, SAP CGTO Solutions Architect

Gilead Sciences, Inc.

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Remote or Santa Monica, California, USA

Full-time

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro
Posted 47 days ago | Updated 4 hours ago

Sr. Director, Cyber Warfare Business Development

Parsons Services Company

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Remote

Full-time

In a world of possibilities, pursue one with endless opportunities. Imagine Next! When it comes to what you want in your career, if you can imagine it, you can do it at Parsons. Imagine a career working with exceptional people sharing a common quest. Imagine a workplace where you can be yourself. Where you can thrive. Where you can find your next, right now. We've got what you're looking for. Job Description: Parsons is looking for an amazingly talented Sr. Director, Cyber Warfare Business De
Posted 60+ days ago | Updated 4 hours ago

Controls Assessment & Testing Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

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Remote or Buffalo, New York, USA

Full-time

The Bank sponsors individuals for TN and H-1B transfers on a case by case basis. Please note that this position is not open to anyone on a H-1B or F-1 student visa including those eligible for CPT/OPT or the Stem OPT extension. Overview: Leads risk analysis for complex initiatives, influencing overarching risk framework and providing advanced guidance to leadership for informed decision-making aligned with organizational imperatives. Primary Responsibilities: Develop and implement strategic ap
Posted 60+ days ago | Updated 4 hours ago

Regulatory Specialist

NavaTech LLC

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Maryland, USA

Third Party, Contract

Regulatory Specialist Location: Hybrid: 2 4 Days Onsite presence required in Leesburg or Tysons, VA (Subject to change) This is a contract-to-hire position. Job Description: Regulatory Affairs Specialist with a strong understanding of FDA regulatory processes for drugs, medical devices, or both. The ideal candidate will serve as a Subject Matter Expert (SME), offering in-depth guidance on the end-to-end regulatory lifecycle, including pre-submission planning, documentation requirements, and f