regulatory affairs Jobs in new york, ny

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Director, Global Regulatory Affairs - Global Labeling Strategy

Sanofi

Morristown, New Jersey, 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

Sr. Regulatory affairs Consultant-W2 ONLY

VetForce Solutions

Remote

Contract

Sr. Regulatory affairs Our client is a rapidly expanding biotech company based in China that recently partnered with a major pharmaceutical company for research collaboration efforts, in hopes of discovering and developing novel oral drug candidates across multiple therapeutic indications (oncology, immunology, etc.) Our client is looking to bring on a Senior Regulatory Affairs Consultant (Senior/Director Level), who will provide strategic regulatory guidance as the client navigates the regulato

Senior Regulatory Project Manager (Banking)

New Millennium Consulting

New York, New York, USA

Contract, Third Party

Job Title: Senior Regulatory Project Manager Job Location: New York, New York Job Type: Contract Experience: 10 Years + A global bank is seeking a Regulatory Project Manager. The Regulatory Project Manager has 10+ years of relevant experience (or training equivalent). This position will report directly to the Head of Program Management for Regulatory Affairs. This role is responsible for delivering key and complex projects within the Regulatory Affairs Program portfolio. Responsible for the deli

Regulatory Studio CMS Senior Manager

Digitive LLC

New Brunswick, New Jersey, USA

Contract, Third Party

Job Title: Regulatory Studio CMS Senior Manager Location: New Brunswick (preferred), Lawrenceville (Hybrid) Experience: 10 years 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 higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience

Regulatory Studio CMS Senior Manager

Digitive LLC

New Brunswick, New Jersey, USA

Contract

Job Title: Regulatory Studio CMS Senior Manager Work location: New Brunswick (preferred), Lawrenceville , NJ Monday thru Friday - Normal business hours, with some flexibility 50% onsite - Team is onsite Monday thru Thursday Term:Contract Pay Rate - $47/hr on w2 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 h

Process Engineer

Katalyst Healthcares and Lifesciences

Jersey City, New Jersey, 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, id

Data Risk Appetite Sr Group Manager, Director

Citi

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

GRA Device Lead (Director)

Sanofi

Morristown, New Jersey, 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

Engineer III, Validation

Thermo Fisher Scientific

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

GRA CMC Project Lead

Sanofi

Morristown, New Jersey, 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

DESIGN LEAD ARCHITECTURAL

City of New York

Queens, New York, USA

Full-time

Company Description Job Description The NYC Department of Environmental Protection (DEP) enriches the environment and protects public health for all New Yorkers by providing 1.1 billion gallons of high-quality drinking water, managing wastewater and storm water, and reducing air, noise, and hazardous materials pollution. DEP is the largest combined municipal water and wastewater utility in the country, with nearly 6,000 employees. DEP's water supply system is comprised of 19 reservoirs and 3 c

Associate Director - Hematology, Oncology Data Sciences & Digital Health

Johnson & Johnson

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

Regulatory CMS Senior Manager

Sureminds Solutions

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

Lead, Regulatory Data

Sanofi U.S.

Morristown, New Jersey, USA

Full-time

Job Title: Lead, Regulatory Data 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. The Lead, Regulatory Data is a strong project leader and expert business analyst who can combine consulting, information quality excellence and digital expertise with pharmaceutical a

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

Boeing Company

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

Principal Engineer, R&D NPI Lead

Johnson & Johnson

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 Supplements

Apptad Inc

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

Senior Specialist - Technology and Cybersecurity Risk

M&T BANK CORPORATION

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 Systems

Katalyst Healthcares and Lifesciences

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

Sr Manager, IT Business Analysis - SAP BRH Architect

Gilead Sciences, Inc.

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