1,569 Results for

Regulatory Affairs Jobs in Wall Street, 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.

9 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.

11 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 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

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

Basking Ridge, NJ

$162,400–$243,600 / year
Full time

30+ 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.

3 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.

9 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

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.

2 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.

1 day ago

Specialty Business Manager, Derm - Bronx, NY Takeda Pharmaceutical

Bronx, NY

Remote

$63.51–$87.31 / hour
Quick Apply

1 day ago

Dermatology Specialty Account Manager Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour
Quick Apply

1 day ago

Pharmaceutical Sales Specialist Takeda Pharmaceutical

Bronx, NY

Remote

$63.51–$87.31 / hour
Quick Apply

1 day ago

Pharmaceutical Account Manager Takeda Pharmaceutical

New York, NY

Remote

$63.51–$87.31 / hour
Quick Apply

1 day 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

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).

13 days ago

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Regulatory Affairs Jobs in Wall Street, 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 Strategist Aquestive Therapeutics Inc.

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

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

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

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

Associate Director, Companion Diagnostics Leader Daiichi Sankyo, Inc.

Director, GVP Quality Assurance Daiichi Sankyo, Inc.

Specialty Pharmaceutical Sales Representative Takeda Pharmaceutical

Specialty Business Manager, Derm - Bronx, NY Takeda Pharmaceutical

Dermatology Specialty Account Manager Takeda Pharmaceutical

Pharmaceutical Sales Specialist Takeda Pharmaceutical

Pharmaceutical Account Manager Takeda Pharmaceutical

Director, Healthcare Compliance Aquestive Therapeutics Inc.

Regulatory Affairs Associate I IntelliPro Group Inc.

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

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