1,583 Results for

Regulatory Affairs Jobs in Cooper, NY

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Regulatory Affairs Specialist Nesco Resource, LLC

Melville, NY

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Very well-established and highly successful domestic and international medical device manufacturer has an exciting career opportunity for a highly talented and well-experienced Regulatory Affairs Specialist with FDA experience who will report directly into the Regulatory Affairs Manager. Communicate the requirements for 510K submittal to appropriate cross functional teams to help facilitate continuous internal process improvement activities assuring compliance to regulatory requirements (i.e. GMP principles, SOP's).

2 days ago

Quality Assurance and Regulatory Affairs Lead Canfield Scientific, Inc.

Parsippany-Troy Hills, NJ

Full time

The Quality Assurance and Regulatory Affairs Lead is responsible for assisting the Quality Assurance team with day-to-day activities in support of companywide quality assurance procedures. The right candidate will have excellent written/verbal communication skills, strong attention to detail, and work well in fast paced environment.

2 days ago

Regulatory Affairs Specialist System One

Lyndhurst, NJ

$28–$35 / hour
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Respond to internal and external compliance inquiries regarding TSCA, PFAS, RoHS, Conflict Minerals, and related requirements. Partner with R&D, Procurement, Product Management, Operations, EHS, Legal, Marketing, and Sales teams to ensure compliance.

Today

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

Carlstadt, NJ

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Nice to have: direct experience with ChemStewards or a comparable EHS&S system (Responsible Care®, RC14001); experience in dispersion, emulsion, or polymer manufacturing; prior work at a growing or newly acquired manufacturer where systems were being built, not inherited. You'll spend time in production areas requiring PPE (safety glasses, footwear, gloves, and periodic respiratory protection), and should be comfortable standing/walking for extended periods, climbing stairs and ladders, and occasionally lifting up to 50 lbs.

7 days ago

Project Manager (Director Level), Medical Affairs # 26-25834 US Tech Solutions, Inc.

Parsippany, NJ

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The Project Manager collaborates closely with Medical Affairs leaders, Medical Scientists, Clinical Development, Evidence Generation, Publications, Medical Operations, Compliance, Commercial, and other cross-functional stakeholders to drive effective planning, governance, communication, and execution of key initiatives. This role enables Medical Affairs leaders and scientific teams to focus on external engagement, evidence generation, and medical strategy by ensuring that critical initiatives are executed efficiently, compliantly, and with measurable impact across the organization.

10 days ago

Engr 2, Product Development /R&D Engineer Kaygen Inc.

Franklin Lakes, NJ

$40–$47 / hour
Temporary
Contractor
Full time
Quick Apply

The MDVC platform depends on a steady flow of well-vetted design changes, including material, component, packaging, and supplier changes, to offset cost pressure while protecting quality on high-volume products such as syringes, needles, and flush. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

2 days ago

Director, Healthcare Compliance Aquestive Therapeutics Inc.

Warren, NJ

Reporting to the Chief Legal Officer & Chief Compliance Officer, this position serves as the Company's primary healthcare compliance leader and strategic advisor to Commercial, Medical Affairs, Market Access, Patient Services, Regulatory Affairs, and other business functions. Key Internal Partners: Legal, Commercial, Medical Affairs, Market Access, Regulatory Affairs, Finance, Human Resources, Quality, Patient Services, and Executive Leadership.

30+ days ago

Specialty Pharmaceutical Sales Representative Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour
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Establish professional working relationships with Health Care Providers decision makers, support staff, and other stakeholders within assigned customers, to support the safe and effective use of the company's products - through developing and applying clinical and business expertise, and effective selling skills. Utilize discretion and judgment to execute the franchise and company brand strategy and tactics within the assigned customer segment, which may include physicians within specialty medical practices and their staff, specialists within local hospitals, clinics, and support staff as well as pharmacists within a specific geographic area.

Today

Pharmaceutical Sales Specialist Takeda Pharmaceutical

Bronx, NY

Remote

$63.51–$87.31 / hour
Quick Apply

Today

Pharmaceutical Account Manager Takeda Pharmaceutical

Bronx, NY

Remote

$63.51–$87.31 / hour

1 day ago

Dermatology Specialty Account Manager Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour

1 day ago

Specialty Business Manager, Derm - Bronx, NY Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour

1 day ago

QA Product Manager (Sterile Products) System One

Florham Park, NJ

Quick Apply

Lead and coordinate end-to-end technology transfer projects for drug substance and/or drug product between R&D, manufacturing sites, and external partners (CMOs/CDMOs) including review of all technical documentation (gap assessments, comparability protocols, equipment qualification, and validation protocols/reports.). Lead the Quality Assurance activities for sterile pharmaceutical products manufactured by third-party manufacturers including change controls, product quality incidents, deviations, non-conformances, out of specification/out of trend investigations, product complaints and CAPAs.

3 days ago

Executive Medical Director, Clinical Development - M.D. (Nephrology) Top Echelon

Jersey City, NJ

Quick Apply

The Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.

7 days ago

Regulatory Affairs Associate I IntelliPro Group Inc.

Clark, NJ

$30–$36 / hour

This role will focus on reviewing product formulas and artwork for regulatory compliance, supporting product notification and registration processes, and maintaining documentation related to regulatory requirements. Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more.

30+ days ago

Regulatory Affairs Senior Manager, Regulatory Information & Content Management Becton Dickinson and Co

Franklin Lakes, NJ

$172,000–$275,200 / year

Primary Responsibilities: Lead Global Regulatory Information and Content Management: Provide strategic and operational leadership for global regulatory information, regulatory content, digital capabilities supporting document and submission management, and assigned digital platforms, ensuring alignment with regulatory strategy, business needs, and the broader Digital RA roadmap. The Senior Manager, Regulatory Information & Content Management is responsible for developing, executing, and maintaining the global Regulatory Affairs strategy and roadmap for regulatory information, regulatory content, and the digital platforms that support their management across Business Units and Regions, in alignment with the broader Digital RA strategy and with specific responsibility for the Regulatory Information Management System (RIM).

6 days ago

Associate Director, Regulatory Affairs - Power Platform Solutions Specialist Merck & Co Inc

Rahway, NJ

$129,000–$203,100 / year

Required Skills: Business Applications Development, Change Controls, Data Engineering, Defects Management, Microsoft Dataverse, Microsoft Power Apps, Microsoft Power Automate, Microsoft Power Platform Copilot, Problem Solving, Release Management, Root Cause Analysis (RCA), Software Testing, Technical Troubleshooting. Identify opportunities to improve the current system, bring innovative enhancement ideas, remain versed in new and emerging Power Platform tools, design capabilities, and user-interface development approaches supporting modernized Power Apps UI and usability, efficiency, and long-term platform value.

22 days ago

Senior Manager, Regulatory Affairs, CMC Shionogi Inc.

Florham Park, New Jersey

$140,000–$170,000 / year

Demonstrated ability to collaborate effectively with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to achieve regulatory milestones and drive product development initiatives forward. Work closely with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment of CMC regulatory requirements with overall product development plans and timelines.

30+ days ago

Senior Specialist, Regulatory Affairs ImmunityBio

Summit, NJ

Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.

30+ days ago

Regulatory Affairs Specialist OrganOx

Madison, NJ

$120,000–$135,000 / year
Quick Apply

The role works closely with Regulatory Affairs team members responsible for software, hardware, disposable products, labelling, and other regulatory disciplines to support submission activities, maintain accurate regulatory records, and ensure alignment across product areas and markets. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant.

30+ days ago

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Regulatory Affairs Jobs in Cooper, NY

Regulatory Affairs Specialist Nesco Resource, LLC

Quality Assurance and Regulatory Affairs Lead Canfield Scientific, Inc.

Regulatory Affairs Specialist System One

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

Project Manager (Director Level), Medical Affairs # 26-25834 US Tech Solutions, Inc.

Engr 2, Product Development /R&D Engineer Kaygen Inc.

Director, Healthcare Compliance Aquestive Therapeutics Inc.

Specialty Pharmaceutical Sales Representative Takeda Pharmaceutical

Pharmaceutical Sales Specialist Takeda Pharmaceutical

Pharmaceutical Account Manager Takeda Pharmaceutical

Dermatology Specialty Account Manager Takeda Pharmaceutical

Specialty Business Manager, Derm - Bronx, NY Takeda Pharmaceutical

QA Product Manager (Sterile Products) System One

Executive Medical Director, Clinical Development - M.D. (Nephrology) Top Echelon

Regulatory Affairs Associate I IntelliPro Group Inc.

Regulatory Affairs Senior Manager, Regulatory Information & Content Management Becton Dickinson and Co

Associate Director, Regulatory Affairs - Power Platform Solutions Specialist Merck & Co Inc

Senior Manager, Regulatory Affairs, CMC Shionogi Inc.

Senior Specialist, Regulatory Affairs ImmunityBio

Regulatory Affairs Specialist OrganOx

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