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Regulatory Affairs Jobs in Jersey City, NJ

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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

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.

1 day ago

Regulatory Affairs Labeling Operations Specialist System One

Plainsboro Township, NJ

Remote

$105,000–$110,000 / year
Quick Apply

We are seeking a dynamic and experienced Regulatory Affairs Labeling Operations Specialist to process critical tasks related to final printed pharmaceutical labeling for launch and lifecycle management projects guided by company content of labeling, FDA Patient Labeling Resources, FDA Label Negotiations and Industry trends. Labeling Tools: Serve as an experienced user in all labeling tools with emphasis in SPL ALiCE A4L environment and proficient in TVT usage; other systems include Vault RIM (Veeva), Esko (LIFT Artwork Management), Adobe Acrobat, etc.) as well as coordinating technical support needs with internal IT groups.

3 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.

26 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.

4 days ago

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

Parsippany, NJ

Quick Apply

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.

7 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

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

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.

14 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.

4 days ago

Associate Director, Medical Information (Oncology) Genmab

Plainsboro, NJ

For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.5c143e31-5e48-4549-b638-05792d185386

12 days ago

Director Corporate Communications System One

Parsippany, NJ

$170,000–$200,000 / year
Quick Apply

The Director will shape corporate storytelling, executive communications, media relations, employee engagement, and digital strategy while translating complex scientific and clinical information into clear, compelling messaging. This is an opportunity to take ownership of corporate communications for a growing, publicly traded biopharmaceutical company and work closely with executive leadership on high visibility initiatives.

4 days ago

Medical Director (Oncology) Genmab

Plainsboro, NJ

15 days ago

Director, Data & Analytics Aquestive Therapeutics Inc.

Warren, NJ

Establish an AI intake and prioritization process that evaluates business value, data readiness, model risk, regulatory impact, security, privacy, explainability, human oversight, and change-management needs. The role defines strategy, establishes governance, builds scalable data capabilities, and partners with business leaders to convert trusted data into measurable business value.

11 days ago

Sr. Director, Global Brand & Portfolio Management CSL

Summit, NJ

$287,000–$352,000 / year

Travel Requirements: 10-20% - Primarily Global Knowledge, Skills & Competencies: Executive leadership and change leadership capabilities Strong strategic thinking, business acumen, and portfolio management expertise Systems-thinking mindset with the ability to connect brand strategies to portfolio outcomes Deep understanding of pharmaceutical and vaccine commercialization, lifecycle management, and product development Demonstrated expertise in strategic planning, governance design, investment prioritization, and resource allocation Strong financial acumen and business case development skills Data-driven decision-making utilizing clinical, real-world evidence (RWE), HEOR, market, and competitive insights Exceptional stakeholder management and influence skills, including the ability to lead without direct authority Outstanding communication, presentation, and executive engagement capabilities Proven success leading cross-functional global teams and building alignment across diverse stakeholders Ability to thrive in ambiguity and lead organizations through change; and Strong analytical, problem-solving, and prioritization skills. Key Relationships: Internal Global Commercial Strategy & Planning (GCS&P) Leadership Team Commercial Operations and Regional Commercial Leadership Research & Development (Clinical Development, Medical Affairs, Regulatory) CEA Global Market Access & Pricing External Partnerships/Business Development Finance Operations/Supply Chain Legal and Compliance External Industry associations Policy organizations Scientific and commercial consultants Market research agencies Promotional agencies Decision Making: This role is responsible for addressing complex strategic, operational, and investment decisions with significant commercial impact.

4 days ago

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Regulatory Affairs Jobs in Jersey City, NJ

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

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

Project Manager, Regulatory Affairs CMC Daiichi Sankyo, Inc.

Regulatory Affairs Labeling Operations Specialist System One

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.

EHS, QMS & Regulatory Specialist Synerfac Technical Staffing

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

Director, Global Labeling Strategist Daiichi Sankyo, Inc.

Associate Director, Consumer US Marketing Daiichi Sankyo, Inc.

Director, Healthcare Compliance Aquestive Therapeutics 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

Associate Director, Medical Information (Oncology) Genmab

Director Corporate Communications System One

Medical Director (Oncology) Genmab

Director, Data & Analytics Aquestive Therapeutics Inc.

Sr. Director, Global Brand & Portfolio Management CSL

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