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Regulatory Affairs Jobs in Brooklyn Heights, NY

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Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.

Basking Ridge, NJ

$166,720–$250,080 / year
Full time

The Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.

30+ 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.

4 days ago

Director, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.

Basking Ridge, NJ

$193,040–$289,560 / year
Full time

The GRL represents Daiichi Sankyo's regulatory group in internal and external development project meetings, provides guidance to peers and cross-functional team members regarding strategic regulatory issues, and develops overall regulatory strategy with input from respective regional strategists for global Health Authority interactions. Serves as a leader of the Global Regulatory Team (GRT) and is responsible for strategic integration of regional strategies, including an understanding of CMC, supply chain and commercialization aspects to support Health Authority requirements.

30+ days ago

Project Manager, Regulatory Affairs CMC Daiichi Sankyo, Inc.

Basking Ridge, NJ

$127,280–$190,920 / year
Full time

With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

6 days ago

Director, Regulatory Affairs, Companion Diagnostics Daiichi Sankyo, Inc.

Basking Ridge, NJ

$184,240–$276,360 / year
Full time

CDx RA Strategy: Represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically: Use of CTA/CDx within clinical trials. Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.

30+ days ago

Regulatory Affairs Specialist System One

Lyndhurst, NJ

$28–$35 / hour
Quick Apply

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.

2 days ago

Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.

Basking Ridge, NJ

$271,500–$452,500 / year
Full time

Ensure all key internal stakeholders are aligned on the approach and the conduct of a global studies/programs that will be implemented in multi-regions (US, Europe, ASCA, Japan)- including Regional Medical, Regional Operations, Safety, Regulatory, Quality, Legal/Compliance, Clinical Supply Operations, Global Program Teams, GMAT Leads, GMA leadership. Responsible for primary data evidence generation delivery of GMA programs: Company Initiated studies (CIS), Non-Interventional Studies (NIS) and Expanded Access Programs (EAP) delivery across countries in Oncology Business Unit and other Regions.

30+ days ago

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

Carlstadt, NJ

Quick Apply

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.

9 days ago

Director, Global Labeling Strategist Daiichi Sankyo, Inc.

Basking Ridge, NJ

$193,040–$289,560 / year
Full time

Serve as a role model for less experienced members of GRA labeling, Labeling Content Management: Manage the preparation, review, and approval of labeling content (including target labeling) for new product submissions, variations, and updates for marketed products, ensuring accuracy, consistency, and regulatory compliance. Cross-functional Collaboration: Serve as the regulatory labeling lead on cross-functional teams, working closely with Regulatory Affairs, Clinical, Medical Affairs, Safety, Legal, and Commercial to enable timely achievement of labeling milestones and project objectives.

30+ days ago

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

Basking Ridge, NJ

$162,400–$243,600 / year
Full time

30+ 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.

4 days ago

Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.

Basking Ridge, NJ

$166,720–$250,080 / year
Full time

Contributes to CDx project teams for the diagnostic, under the direction of the Global Program Teams (GPT) CDx representative for the therapeutic or under the guidance of the CDx portfolio leader, covering all areas from CDx assay development through CDx approval and launch. Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liaisons to ensure successful implementation of CDx and data collection.

30+ days 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.

5 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.

9 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).

8 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.

24 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

Manager Rates and Regulatory Affairs - NJ Finance & Regulatory FirstEnergy Corp

Morristown, NJ

$157,590–$222,480 / year

Given the complexity of New Jersey''s regulatory environment, the frequency and significance of ongoing regulatory proceedings, and the need to protect both customer and shareholder interests, backfilling this position is necessary to maintain continuity of expertise, preserve key stakeholder relationships, support critical business initiatives, and ensure successful execution of JCP&L''s regulatory and financial objectives. We are committed to rewarding individual and team efforts through our total rewards philosophy which includes competitive pay plus incentive compensation, a company-sponsored pension plan, 401 (k) savings plan with matching employer contribution, a choice of medical, prescription drug, dental, vision, and life insurance programs, as well as skills development training with tuition reimbursement.

11 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

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Regulatory Affairs Jobs in Brooklyn Heights, NY

Associate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.

Quality Assurance and Regulatory Affairs Lead Canfield Scientific, Inc.

Director, Global Regulatory Affairs (GRL) Daiichi Sankyo, Inc.

Project Manager, Regulatory Affairs CMC Daiichi Sankyo, Inc.

Director, Regulatory Affairs, Companion Diagnostics Daiichi Sankyo, Inc.

Regulatory Affairs Specialist System One

Head, Global Oncology Medical Affairs, Clinical Trial Management, Resources, Operations & Governance Daiichi Sankyo, Inc.

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

Director, Global Labeling Strategist Daiichi Sankyo, Inc.

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

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

Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.

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.

Manager Rates and Regulatory Affairs - NJ Finance & Regulatory FirstEnergy Corp

Senior Specialist, Regulatory Affairs ImmunityBio

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