Regulatory Affairs Jobs in Boston, MA

1 - 20 of 25 Jobs

Director, Global Regulatory Affairs - Global Labeling StrategyJob Title - Director, Global Regulatory Affairs - Global Labeling Strategy

SanofiCompany Name - Sanofi

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Cambridge, Massachusetts, USA

Full-time

Job Title: Director, Global Regulatory Affairs - Global Labeling Strategy Location: Morristown, NJ (preferred), Cambridge, MA, Swiftwater, PA or Washington, DC About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Director, Global Regulatory Affairs - Global Labeling Strategy is responsible for leading the

Senior Process EngineerJob Title - Senior Process Engineer

Katalyst Healthcares and LifesciencesCompany Name - Katalyst Healthcares and Lifesciences

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Boston, Massachusetts, USA

Full-time

Responsibilities: This role is responsible for providing technical support regarding the execution of 4 Process Performance Qualifications (PPQ) by visiting the tech transfer receiving sites and evaluating the current state of operational readiness through the execution of pFMEA for each site. Develop and execute current state operational readiness assessment pFMEAs. Report findings with recommendations and escalate critical risks/gaps identified timely. Support resolution of identified gaps

GRA Device Lead (Director)Job Title - GRA Device Lead (Director)

SanofiCompany Name - Sanofi

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Cambridge, Massachusetts, USA

Full-time

Job Title: GRA Device Lead (Director) Location: Morristown, NJ, Cambridge, MA, Framingham, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The GRA Device team is a globally diverse team supporting the medical device, combination product, digital health and in-vitro diagnostic products within the Sano

GRA Device Lead (Director)Job Title - GRA Device Lead (Director)

SanofiCompany Name - Sanofi

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Framingham, Massachusetts, USA

Full-time

Product Safety EngineerJob Title - Product Safety Engineer

SharkNinjaCompany Name - SharkNinja

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Needham, Massachusetts, USA

Full-time

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people's lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja, the company has a proven track record of bringing disruptive innovation to market, and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains

Clinical Lead, Early Clinical and Experimental TherapeuticsJob Title - Clinical Lead, Early Clinical and Experimental Therapeutics

SanofiCompany Name - Sanofi

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Cambridge, Massachusetts, USA

Full-time

Job DescriptionJob Title: Clinical Lead, Early Clinical and Experimental Therapeutics Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. Join our state-of-the-art ECET department as a Clinical Lead, ECET and you ll drive the translation between preclinical development t

R&D EngineerJob Title - R&D Engineer

Cardinal HealthCompany Name - Cardinal Health

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Mansfield, Massachusetts, USA

Full-time

What Research and Development Engineering contributes to Cardinal Health Engineering is responsible for performing research and analyses to develop design options for components, products, systems and processes. Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices. Job Description: Under the direction of the Manager of R&D, this individual will

GRA CMC Project LeadJob Title - GRA CMC Project Lead

SanofiCompany Name - Sanofi

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Framingham, Massachusetts, USA

Full-time

Job Title: GRA CMC Project Lead Location: Morristown, NJ Framingham, MA About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Chemistry, Manufacturing and Controls (CMC) regulatory team is accountable for the global regulatory strategy for development and marketed products within GRA. The team responsibil

Principal C++ Software Engineer - Med DeviceJob Title - Principal C++ Software Engineer - Med Device

Motion Recruitment Partners, LLCCompany Name - Motion Recruitment Partners, LLC

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Boston, Massachusetts, USA

Full-time

Our client is an innovative, venture-backed medical technology company developing next-generation imaging solutions to enhance surgical precision and improve patient outcomes. They are seeking a Principal Software Engineer with deep expertise in C++, CUDA, and image processing to help lead development of real-time imaging software for surgical applications. Position Summary: This role will focus on designing and optimizing software systems that utilize visible and near-infrared imaging technolo

Regulatory CMS Senior ManagerJob Title - Regulatory CMS Senior Manager

Sureminds SolutionsCompany Name - Sureminds Solutions

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Remote

Contract, Third Party

C2C Role Please share Profiles at Hi, Urgent need, Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Top 3 to 5 skills/Must Haves: Small Molecule Drug development experience (2 to 3 years) Good communications skills (written/verbal) Experience with Veeva System PREREQUISITES BS/BA degree in Scientific Discipline (master's or hig

Senior Engineer, Design Transfer SpecialistJob Title - Senior Engineer, Design Transfer Specialist

Amgen IncCompany Name - 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

Associate Engineering Fellow, Process EngineeringJob Title - Associate Engineering Fellow, Process Engineering

Takeda pharmaceuticalCompany Name - Takeda pharmaceutical

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Cambridge, 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 Synthetic Molecule Process Development (SMPD) is responsible for the development of robust, sustainable, and cost-effective processes

Field Service Engineer 1Job Title - Field Service Engineer 1

GE HealthcareCompany Name - GE Healthcare

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Remote

Full-time

Job Description Summary Job Summary The Field Service Engineer provides customer site support for all products within their assigned area of responsibility. The FSE serves as the technical liaison between the customer and manufacturing operations. They are responsible for maintaining and repairing equipment on-site and returning it to operational status as quickly as possible while minimizing service costs. This position requires the ability to work independently or in a team environment, must h

Classification and Trade Data Specialist (Mid-Level or Senior)Job Title - Classification and Trade Data Specialist (Mid-Level or Senior)

Boeing CompanyCompany Name - Boeing Company

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Remote or Dallas, Texas, USA

Full-time

Classification and Trade Data Specialist (Mid-Level or Senior) Company: The Boeing Company The Boeing Company is seeking a Classification and Trade Data Specialist (Mid-Level or Senior) to join their team in Dallas, TX. This role ensures our products are accurately classified for importation and exportation from our nine global warehouse locations. The candidate will have a strong knowledge of established classification methodologies utilizing the Harmonized Tariff Schedule and Order of Revie

Data Risk Appetite Sr Group Manager, DirectorJob Title - Data Risk Appetite Sr Group Manager, Director

CitiCompany Name - 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

Principal Engineer, R&D NPI LeadJob Title - Principal Engineer, R&D NPI Lead

Johnson & JohnsonCompany Name - Johnson & Johnson

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Remote or Jacksonville, Florida, 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

Principal Regulatory Consultant Dietary SupplementsJob Title - Principal Regulatory Consultant Dietary Supplements

Apptad IncCompany Name - Apptad Inc

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New Jersey, USA

Contract, Third Party

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

Engineer III, ValidationJob Title - Engineer III, Validation

Thermo Fisher ScientificCompany Name - 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

Senior Specialist - Technology and Cybersecurity RiskJob Title - Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATIONCompany Name - 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

Computer System Validation Analyst - R Studio & Clinical SystemsJob Title - Computer System Validation Analyst - R Studio & Clinical Systems

Katalyst Healthcares and LifesciencesCompany Name - 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