1,583 Results for

Regulatory Affairs Jobs in Union City, NJ

Jobs

Quality Assurance and Regulatory Affairs Associate 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.

19 days ago

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

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.

4 days ago

Regulatory Operations/Global Regulatory Affairs Intern Daiichi Sankyo, Inc.

Basking Ridge, NJ

$17.23–$58.15 / hour

The Regulatory Automation & AI Developer Intern will support the Global Regulatory Operations team in designing, developing, and implementing innovative automation and artificial intelligence solutions that improve operational efficiency, quality, and regulatory submission processes. The intern will work closely with regulatory operations, business process owners, and technology teams to identify opportunities for automation, develop proof-of-concept solutions, and help deploy scalable tools that enhance productivity and decision-making.

4 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.

21 days ago

Global Regulatory Affairs Labeling Intern Daiichi Sankyo, Inc.

Basking Ridge, NJ

$17.23–$58.15 / hour
Full time

4 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.

3 days ago

Regulatory Affairs Strategist Aquestive Therapeutics Inc.

Warren, NJ

This role serves as a key liaison between the company and regulatory agencies, ensuring compliance with applicable regulations while facilitating timely submissions for clinical trials, marketing authorizations, and post-approval changes. Working cross-functionally with R&D, Clinical, Quality, CMC, and Commercial teams, the strategist provides regulatory guidance throughout all phases of product development.

30+ 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

Manager, Global Oncology Medical Affairs Governance Daiichi Sankyo, Inc.

Basking Ridge, NJ

$127,280–$190,920 / year
Full time

Governance Oversight: Lead and continuously improve the maintenance and implementation of governance frameworks to ensure robust oversight of the global oncology review process for company-funded clinical studies, expanded access programs, and other related functions. The GOMA Governance Review Committee Office Manager leads evidence generation governance, operational oversight, and compliance of the global oncology review process for company-funded clinical studies, expanded access programs (EAP), and other related functions.

4 days ago

Global Oncology Medical Affairs Intern Daiichi Sankyo, Inc.

Basking Ridge, NJ

$17.23–$58.15 / hour

4 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.

8 days ago

Senior Director, Global Clinical Supply Quality Assurance Daiichi Sankyo, Inc.

Basking Ridge, NJ

$209,850–$349,750 / year
Full time

Strategic Leadership & Oversight and Cross-Functional Team Participation: Cross-Functional Team Participation: Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products; Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder. Drug Product Release and Oversight of Clinical Trial Materials Lifecycle: Drug Product Release: Exercise leadership in order to execute a comprehensive drug product release program for commercial and investigational drug products and assures that all external contractors involved in manufacturing and testing provide GMP compliant release documentation ensuring satisfactory QA review and approval of drug product master production records.

13 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.

19 days ago

Executive Director, Early Specialty Medicine Global Clinical Lead Daiichi Sankyo, Inc.

Basking Ridge, NJ

$329,025–$548,375 / year
Full time

The role helps influence the strategic direction of the Specialty Medicine portfolio and spans immunology, the newly established ophthalmology program, cardiovascular disease, and other emerging therapeutic areas, combining broad early-development expertise with end-to-end global development judgment from preclinical development through Phase 3. When needed, the role may be called upon to provide input on late-stage development and regulatory strategy. Demonstrated innovation and speed across modalities and therapeutic areas; a track record of shaping clinical development and portfolio strategy and influencing senior leadership decisions; global development experience spanning preclinical development through Phase 3; and senior-level accountability for independent development decisions, portfolio judgment, BD due diligence, governance representation, and external engagement is required.

4 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

Director, GVP Quality Assurance Daiichi Sankyo, Inc.

Basking Ridge, NJ

$201,840–$302,760 / year
Full time

Together with Regional DSI Management teams, plans, supports, conduct and reports pre-clinical, Clinical Research (GCP), Pharmacovigilance (PV) and Global Medical affairs (GMA) audits/inspections at regional level and support across the organization and affiliates. Corrective and Preventative Action (CAPA) Plans and CAPA Effectiveness Check Responsible for review, track and ensure the completion for CAPA plans provided by vendors as part of monitoring activities for Vendor Qualification Program.

12 days ago

Specialty Pharmaceutical Sales Representative Takeda Pharmaceutical

Bronx, NY

Remote

$63.51–$87.31 / hour
Quick Apply

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.

3 days ago

Pharmaceutical Account Manager Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour
Quick Apply

3 days ago

Dermatology Specialty Account Manager Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour
Quick Apply

3 days ago

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Regulatory Affairs Jobs in Union City, NJ

Quality Assurance and Regulatory Affairs Associate Canfield Scientific, Inc.

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

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

Regulatory Operations/Global Regulatory Affairs Intern Daiichi Sankyo, Inc.

Project Manager, Regulatory Affairs CMC Daiichi Sankyo, Inc.

Global Regulatory Affairs Labeling Intern Daiichi Sankyo, Inc.

Regulatory Affairs Specialist System One

Regulatory Affairs Strategist Aquestive Therapeutics Inc.

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

Manager, Global Oncology Medical Affairs Governance Daiichi Sankyo, Inc.

Global Oncology Medical Affairs Intern Daiichi Sankyo, Inc.

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

Senior Director, Global Clinical Supply Quality Assurance Daiichi Sankyo, Inc.

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

Executive Director, Early Specialty Medicine Global Clinical Lead Daiichi Sankyo, Inc.

Director, Healthcare Compliance Aquestive Therapeutics Inc.

Director, GVP Quality Assurance Daiichi Sankyo, Inc.

Specialty Pharmaceutical Sales Representative Takeda Pharmaceutical

Pharmaceutical Account Manager Takeda Pharmaceutical

Dermatology Specialty Account Manager Takeda Pharmaceutical

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