Regulatory affairs Jobs

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Regulatory Affairs Manager V - Clearance DesiredJob Title - Regulatory Affairs Manager V - Clearance Desired

LMI Government Consulting (Logistics Management InCompany Name - LMI Government Consulting (Logistics Management In

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Remote

Contract

Overview LMI is seeking an experienced Regulatory Affairs Manager to support our Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear (JPEO-CBRND) Regulatory Affairs and Quality Assurance (RAQA) client at our Ft. Detrick, MD location. Will serve as lead auditor for quality audits (GMP & GLP) of developing and manufacturing investigational countermeasures for MCS. LMI is a consultancy dedicated to powering a future-ready, high-performing government, drawing from expe

Program Manager Quality/Clinical/Regulatory Affairs Jr - 1st Shift - HybridJob Title - Program Manager Quality/Clinical/Regulatory Affairs Jr - 1st Shift - Hybrid

VIVA USA INCCompany Name - VIVA USA INC

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Deerfield, Illinois, USA

Contract

Title: Program Manager Quality/Clinical/Regulatory Affairs Jr - 1st Shift - Hybrid Mandatory skills: Project Management Microsoft Project, Excel, PowerPoint pharmaceutical, medical manufacturing GMP, PMBOK project planning, project leadership, project risk program schedule, program execution, risk plan, risk response business case, business scope, business schedule, business resource plans proactive management, proactive solutions, performance metrics, regulatory guidelines, continuous im

Quality Regulatory Affairs ScientistJob Title - Quality Regulatory Affairs Scientist

Cynet SystemsCompany Name - Cynet Systems

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Glenview, Illinois, USA

Third Party, Contract

We are looking for Quality Regulatory Affairs Scientist for our client in Glenview, IL Job Title: Quality Regulatory Affairs Scientist Job Location: Glenview, IL Job Type: Contract Job Description: Pay Range: $13hr - $18hr Key Components:Provide technical information and evaluating regulatory compliance of products as well as adhering to internal policies and guidelines for exporting products.Review label graphics for regulatory compliance and technical accuracy in conjunction with the local Reg

Director, Regulatory Affairs Advertising/PromotionJob Title - Director, Regulatory Affairs Advertising/Promotion

Milestone Technologies, Inc.Company Name - Milestone Technologies, Inc.

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Foster City, California, USA

Full-time

Director, Regulatory Affairs Advertising/Promotion FOSTER CITY 2-3 days onsite weekly No direct reports Reg Affairs - Advertising and Promotion Salary Range: 233-265k Local Candidates only No Sponsorship is offered at this time Director, Regulatory Affairs Advertising/Promotion POSTION SUMMARY The Director, Regulatory Affairs Advertising/Promotion will provide leadership, insight, and clear direction on all advertising and promotional programs and tactics that are compliant with regulations

Vice President, Regulatory AffairsJob Title - Vice President, Regulatory Affairs

Civica RxCompany Name - Civica Rx

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Petersburg, Virginia, USA

Full-time

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs

Regulatory Affairs SpecialistJob Title - Regulatory Affairs Specialist

Dynamic Enterprise Solutions IncCompany Name - Dynamic Enterprise Solutions Inc

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North Chicago, Illinois, USA

Third Party, Contract

Accountability / Scope: As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration in EURI/MENAP global. Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any deficiencies and develop approach to solutions. Individual shall be good with excel and numbers, so that they can help analyze su

Sr. Manager Regulatory AffairsJob Title - Sr. Manager Regulatory Affairs

Milestone Technologies, Inc.Company Name - Milestone Technologies, Inc.

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Remote

Contract

100% Remote - PST Hours W2 (ONLY) 12+ month Contract Must have knowledge of CMC regulations and experience using SCA and/or GenAI tools. Experience with FHIR is a plus. CMC Template Automation Milestone Technologies Inc. is seeking a Sr. Regulatory Affairs Specialist to design and configure regulatory authoring templates that are needed for deployment of automation software for use in preparing chemistry, manufacturing, and controls (CMC) regulatory applications (ex. Module 3 of the ICH Common

CMC 2 Regulatory affairs / Animal Health CareJob Title - CMC 2 Regulatory affairs / Animal Health Care

Net2Source Inc.Company Name - Net2Source Inc.

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No location provided

Contract

Job Title: CMC 2 Regulatory affairs / Animal Health Care Location: Remote Hire Type: 6+ Month Contract (Extendable) Responsibilities: " Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States " Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, respons

Regulatory Affairs ManagerJob Title - Regulatory Affairs Manager

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Danvers, Massachusetts, USA

Full-time

Description Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Manager, located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by the Company. 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 experti

Manager, Global Regulatory Affairs CMCJob Title - Manager, Global Regulatory Affairs CMC

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Boston, Massachusetts, USA

Full-time

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requ

Senior Manager, Regulatory Affairs IVDJob Title - Senior Manager, Regulatory Affairs IVD

Regeneron PharmaceuticalCompany Name - Regeneron Pharmaceutical

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Tarrytown, New York, USA

Full-time

Regeneron is advancing its pipeline portfolio using a data-driven human translational approach. The In Vitro Diagnostic (IVD) Regulatory Affairs (RA)Team along with the Regulatory Affairs Global Regulatory Strategy Group (GRS) collaborate with the Precision Medicine and Clinical Sciences Teams to help develop and execute biomarker strategies across its growing clinical portfolio. The Sr. Manager, Regulatory Affairs IVD will work closely with their RA GRS counterparts, the Companion Diagnostics (

Manager, Global Regulatory Affairs CMC Submissions ManagementJob Title - Manager, Global Regulatory Affairs CMC Submissions Management

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Lexington, Massachusetts, USA

Full-time

Regulatory Affairs Program ManagerJob Title - Regulatory Affairs Program Manager

Philips North AmericaCompany Name - Philips North America

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Cambridge, Massachusetts, USA

Full-time

Job Title Regulatory Affairs Program Manager Job Description As a Regulatory Affairs Program Manager, you will be an important member of the Philips Regulatory Affairs Centralized Services Team, committed to improving billions of lives worldwide. Your role: Will own and manage the Philips wide strategy and execution of FDA Establishment Registrations and Listings across the enterprise.Maintain controlled processes and guidance documents for FDA Establishment Registrations and Listings in the

Principal Regulatory Affairs Specialist-UltrasoundJob Title - Principal Regulatory Affairs Specialist-Ultrasound

Philips North AmericaCompany Name - Philips North America

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Bothell, Washington, USA

Full-time

Job Title Principal Regulatory Affairs Specialist-Ultrasound Job Description The Principal Regulatory Affairs Specialist will play a critical role in preparing comprehensive regulatory strategies for complex new devices and post market changes within Philips' Ultrasound business. Your role: Lead business critical new product development projects, provide regulatory oversight to maintain lifecycle ensuring that the state-of-the-art requirements are maintained Develop regulatory strategies and

Director of Regulatory Affairs & QualityJob Title - Director of Regulatory Affairs & Quality

Philips North AmericaCompany Name - Philips North America

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Plymouth, Minnesota, USA

Full-time

Job Title Director of Regulatory Affairs & Quality Job Description The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities. Your role: Leading Regulatory Affairs strategy end-to-end execution (product inception through to lifecycle management), driving innovation, actively providing value-added regulatory af

Regulatory Affairs Specialist IJob Title - Regulatory Affairs Specialist I

Penumbra IncCompany Name - Penumbra Inc

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Alameda, California, USA

Full-time

In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will work under direct supervision and be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions. What You'll Work On Under direct supervision, assist in preparing various submissions to gain approvals, such as: 510(k), CE

Director, Regulatory Affairs - InflammationJob Title - Director, Regulatory Affairs - Inflammation

Gilead Sciences, Inc.Company Name - Gilead Sciences, Inc.

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Foster City, California, USA

Full-time

Job Description 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 pl

Senior Manager CMC Regulatory AffairsJob Title - Senior Manager CMC Regulatory Affairs

Regeneron PharmaceuticalCompany Name - Regeneron Pharmaceutical

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Bernards, New Jersey, USA

Full-time

The candidate will be leading the regulatory strategies for biologic products and combination products for the product portfolio assigned. In this role, a typical day might include the following: Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirementsParticipate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC/CP regu

Senior Director Global Regulatory AffairsJob Title - Senior Director Global Regulatory Affairs

Danaher CorporationCompany Name - Danaher Corporation

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Remote or Fargo, North Dakota, USA

Full-time

At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from

Regulatory Affairs Specialist IIJob Title - Regulatory Affairs Specialist II

Boston Scientific CorporationCompany Name - Boston Scientific Corporation

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Maple Grove, Minnesota, USA

Full-time

Recruiter: Spencer Gregory Hale Regulatory Affairs Specialist II About the role: At Boston Scientific, our products and technologies are used to treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Peripheral Interventions (PI) we design, develop, and produce technologies for diagnosing and treating peripheral artery and venous disease. We are able to provide a number of solu