Regulatory affairs jobs

Canyon Lake, Texas

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Today

Software Guidance & Assistance, Inc., (SGA), is searching for a Senior Manager, Regulatory Affairs for a Full Time assignment with one of our premier Utilities clients in Texas . Responsibilities : Lead regulatory affairs activities for a regulated utility operation, ensuring alignment between business objectives, financial performance, and regulatory requirements. Develop and execute rate case strategies, including preparation of regulatory filings, supporting schedules, and testimony for stat

Full-time

Senior Director of Regulatory Affairs

Cleveland, Ohio

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Today

Senior Director of Regulatory Affairs Job Title: Senior Director of Regulatory Affairs Reports to: Chief Medical Officer Job Overview The Senior Director of Regulatory Affairs will provide strategic and operational leadership for regulatory affairs activities supporting Cleveland Diagnostics\' in vitro diagnostic (IVD) and laboratory developed test (LDT) product portfolio, including tests/assays intended for early cancer detection and other clinical indications. This role will lead the developm

Full-time

USD 125,000.00 - 225,000.00 per year

Project Manager – Quality & Regulatory Affairs

Remote

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14d ago

Hello, Hope you are doing well We are constantly on the lookout for professionals to fulfil the staffing needs of our clients, and we currently have a job opening that may interest you. Job Title:Project Manager Quality & Regulatory Affairs Location: Remote Position Type: Contract for 6 Months Job Summary Position Overview Atlas is seeking an experienced Project Manager to lead complex Quality and Regulatory Affairs initiatives within a regulated life sciences environment. This role will dri

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Contract

Depends on Experience

Senior Regulatory Affairs Specialist

Martinez, California

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Today

DUTIES AND RESPONSIBILITES: Responsible for elicitation, analysis, and documentation of business requirements. Research and exploration of user requirements, costs, and benefits in support of documentation required for the demand management process. Responsible for analyzing the business needs to identify new processes and process improvements that will meet those needs. Documents current business processes and models to define requirements and/or gaps. Analyze detailed system factors inclu

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Contract

Depends on Experience

Regulatory Affairs Specialist Small Molecule

Remote

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2d ago

Job Title: Clinical Regulatory Affairs Specialist Small Molecule Location: Remote We are seeking a Clinical Regulatory Affairs Specialist with 9+ years of experience supporting small molecule clinical development programs.Key Requirements:Strong experience in Clinical Regulatory AffairsHands-on experience with Veeva Vault TMF or similar.Experience with IND, CTA, and NDA submissionsKnowledge of ICH-Google Cloud Platform, FDA, EMA, and global regulatory requirementsExperience supporting clinical

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Contract, Third Party

Depends on Experience

Senior Design Quality Engineer

Andover, Massachusetts

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Today

Role name: Senior Design Quality Engineer Work Location: Andover, MA Start date: Immediate availability. Interview Mode: Phone/Video Type: Contract (C2C/W2) Senior Design Quality Engineer Location: Andover, MA OR Remote Qualifications: Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline Advanced degree (Master s) in Engineering, Quality, or Regulatory Affairs preferred Re

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Full-time, Part-time, Third Party, Contract

Validation Specialist

Hybrid in Raleigh, North Carolina

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Today

Please, no agencies or recruiters, only W2 applicants. Monday to Friday, Hybrid, 3 days in office Job description: The Validation Specialist, Regulatory is responsible for implementing GxP computerized systems for the R&D IT department. A successful candidate will have recent CSA experience, an understanding of relevant US and EU regulations, and familiarity with validating SaaS applications, and AI models. Direct experience with electronic Instructions For Use and electronic Prescribing Informa

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Contract

Depends on Experience

Sr Manager, Global Regulatory Affairs (AI/ML)

Remote

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Today

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making bette

Full-time

USD 170,000.00 - 200,000.00 per year

Senior US Licensing Engineer - Regulatory Affairs (Remote Eligible, U.S.)

Remote

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Today

Job Description Summary The U.S. Senior Licensing Engineer, Regulatory Affairs, will lead the completion of various technical licensing work scopes in the United States, specifically new reactor licensing for BWRX-300 Advanced Nuclear Projects to ensure the successful delivery of new build projects. This role focuses on the technical execution of licensing applications such as Licensing Topical Reports, and applications submitted to the NRC under Part 50 or Part 52. Job Description Roles and R

Full-time

USD 111,200.00 - 213,200.00 per year

Principal Engineer, Regulatory Affairs

Reston, Virginia

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Today

Location(s): Washington, DC Job Schedule: Full-time - Hybrid - in office Monday-Thursday Education Requirement: Bachelor's Sponsorship: No The Principal Engineer / Engineer Governmental & Regulatory Affairs, leads and manages communications and official submissions between Nissan and U.S. Federal, State, and local governments, regulators and other organizations and industry stakeholders on safety and technology related topics. Keeps detailed knowledge of current and emerging safety & tech poli

Full-time

Manager, Regulatory Data and Content, Regulatory Affairs CMC

Foster City, California

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Today

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

Full-time

USD 146,540.00 - 189,640.00 per year

Clinical Quality Assurance Manager

Hybrid in Waltham, Massachusetts

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7d ago

Key Responsibilities & Required Qualifications:: Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or a related discipline.7+ years of experience in Pharmaceutical QA, Quality Operations, or a GMP-regulated environment.Hands-on experience with clinical packaging and labeling operations.Strong experience reviewing and approving clinical packaging/labeling batch records.Knowledge of GMP regulations, deviations, CAPAs, investigations, and change controls.Experience working with Contract

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Contract

70 - 72

Engineering Technician

Omaha, Nebraska

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6d ago

Summary About the Position: This is a development GS-09/10 Engineering Technician with USACE Omaha District, Construction Division located in Omaha, NE. Learn more about this agency Duties Help Review documentation and correspondence developed in the field offices to ensure technical adequacy and conformance to policy and regulatory requirements.Serve as a construction contract administration specialist engaged in the full scope of activities related to construction contracts.Serve as the C

Full-time

USD 62,339.00 - 89,239.00 per year

Licensing Engineer Consultant

Richland, Washington

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Today

Location: Richland, WA Salary: $105.00 USD Hourly - $135.00 USD Hourly Description: Job Title: Licensing Engineer Consultant - Engineering Projects Location: (Onsite) Schedule: Monday-Thursday, 4x10 Per Diem: Yes Summary: Seeking an experienced Licensing Engineer Consultant to provide regulatory and licensing support for major engineering and plant initiatives within a regulated nuclear power generation environment. The role involves collaborating with engineering, project management, regula

Contract

Compensation information provided in the description

Architectural Sr Project Manager

Arlington, Virginia

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Today

What We're Looking For At HNTB, you can create a career that is meaningful to you while building communities that matter to all of us. For more than a century, we have been delivering solutions for some of the largest, most complex infrastructure projects across the country. With our historic growth, it is an exciting time to join our team of employee-owners. This opportunity entails being responsible for leading large and/or complex projects. Responsible for the coordination of all project effo

Full-time

USD 173,075.17 - 276,470.74 per year

Sr. Manager, Engineering R&D

No location provided

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Today

Job Description Manage individuals from entry-level to mid-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties:Manage a group of individuals of varying technical experience from entry-level to mid- level on projects of defined scope and diversity. Direct subordinates toward clear company objectives

Full-time

Engineer

Devils Lake, North Dakota

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Today

Position:Engineer Position #: 540-6166 Job ID #: 3034027 Division:Office of the Adjutant General - Camp Grafton Location: Devils Lake, ND OTAG Starting Salary:Engineer II - $7,005 - $9,339/month ($84,059 - $112,073/annual) (DOE) Engineer I - $5,829 - $7,772/month ($69,949 - $93,267/annual) (DOE) Status: Regular, Full-Time At the North Dakota National Guard, we stand by our mission to provide ready units, individuals and equipment to support our communities, state, and nation. We are looking for

Full-time

USD 7,250.00 - 12,083.00 per month

Manager, Engineering R&D (D-TECT)

No location provided

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Today

Job Description Manage individuals from entry-level to junior-level experience, develop and launch products, research new ideas, and manage overall design history. Focus is on both theoretical and practical solution development through the application of the scientific process and project management. Job duties:Manage a group of individuals of varying technical experience from entry level to junior level on projects of defined scope and diversity. Direct subordinates toward clear company object

Full-time

Global Regulatory Lead

Overland Park, Kansas

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Today

Job#: 3056987 Job Description: Global Regulatory Lead Location: Remote Role Overview The Regulatory Specialist provides strategic regulatory leadership for a late-stage cardiovascular development program, serving as the primary regulatory lead for a key investigational asset. This role drives global regulatory strategies through critical development and registration milestones, including NDA preparation, submission, and review activities. The successful candidate will leverage a strong backg

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Full-time

$105 - $115 per hour

Summer Intern - Licensing Engineer

Hopkins, South Carolina

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Today

Are you interested in being part of an innovative team that supports Westinghouse's mission to provide clean energy solutions? At Westinghouse, we recognize that our employees are our most valuable asset and we seek to identify, attract and recruit the most qualified talent while recognizing and encouraging the value of diversity in the global workplace. About the role: As a summer intern, you will support the development and updates to the Integrated Safety Analysis (ISA) and associated licen

Full-time

USD 25.40 - 29.00 per hour