Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
JouléNewRegulatory Affairs Senior Associate JouléRegulatory Affairs Senior AssociateWarren, NJ$49.15–$49.15 / hour2-4 years’ experience in regulatory affairs including chemistry, manufacturing and controls, and OTC experience, preferably within a CPG/Consumer Healthcare/Pharma industry. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Clinical Dynamix, Inc.NewSenior Director, Regulatory Affairs Clinical Dynamix, Inc.Senior Director, Regulatory AffairsJersey City, NJThe Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department.
JouléNewRegulatory Affairs Senior Manager JouléRegulatory Affairs Senior ManagerWarren, NJ$73–$76 / hourThe purpose of this role is to execute OTC regulatory activities for new products registrations and life-cycle maintenance for the portfolio of products defined by the US Business Units. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Daiichi Sankyo, Inc.NewManager, Regulatory Affairs- CMC Daiichi Sankyo, Inc.Manager, Regulatory Affairs- CMCBasking Ridge, NJ$127,280–$190,920 / yearFull timeWith 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. Execution of Strategy and Submissions: Prepares content templates and supports the technical team in preparation of submission documents for review by higher-level manager.
Company ConfidentialNewManager, Scientific Affairs Company ConfidentialManager, Scientific AffairsParsippany, NJ$100,000–$130,000 / yearFull timeDirectly and effectively partner and collaborate with DSA and DSI Supply Chain, Field Support, Training, Marketing, Quality and Legal to strengthen relationships and mutual trust. Develop, with Director of Market Access, key metrics for staff to ensure project timeliness and manage staff adherence to timelines.
EclaroMedical and Regulatory Affairs - Cell Therapy Medical Communication Specialist EclaroMedical and Regulatory Affairs - Cell Therapy Medical Communication SpecialistLawrence Township, NJ$77.58–$82.28 / hourFull timeResponsibilities:Take on assigned projects to help with development and execution of functionally integrated and aligned medical communications plans; adjust communications plans in accordance with clinical trial results / milestones and changes in the healthcare landscape. In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication.
JouléNewGlobal Regulatory Compliance Manager JouléGlobal Regulatory Compliance ManagerMontville, NJ$115,000–$155,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Conduct global risk assessments, interpret complex multi-regional requirements, and develop strategies to mitigate regulatory risks.
EclaroRegulatory & Medical Affairs - Project Manager EclaroRegulatory & Medical Affairs - Project ManagerLawrence Township, NJ$75.83–$80.43 / hourFull timeExceptional collaboration skills; this role requires daily partnership with a wide range of internal teams, IT partners, and external vendors; the ability to build strong working relationships across all levels is essential. This role requires someone who is equally comfortable driving meetings, managing complex PM documentation, supporting platform operations, and partnering with IT, commercial, and cross-functional matrix teams.
Daiichi Sankyo, Inc.Associate Director, PV Strategic Partner Management Daiichi Sankyo, Inc.Associate Director, PV Strategic Partner ManagementBasking Ridge, NJ$153,600–$230,400 / yearFull timeProvide oversight of ICSR processing activities including, Safety Information submission to Health Authorities and License Partners, Reconciliation with License Partners, Patient Support Programs, Market Research vendors, Global Quality Supply Chain, Medical Information Social Media and other suppliers. Oversees Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety case processing, and aggregate reporting for DSI products, both investigational and marketed.
SOFIEQuality Manager, Partners SOFIEQuality Manager, PartnersTotowa, NJ$90,000–$100,000 / yearThe successful candidate will provide quality assurance management, decision making, and support to the RCM group with specific emphasis on change control, corrective and preventive actions, procedure approval, exception reporting, partner/sponsor communications, validation and qualification reviews, and review and approval of various other documents and reports applicable to new products. This includes making quality related decisions and assisting in the generation, review, and approval of change controls, corrective and preventive actions, procedures, exception reports, protocols, and other documents applicable to new products.
JouléNewRegulatory Compliance Specialist JouléRegulatory Compliance SpecialistMontville, NJ$85,000–$115,000 / yearInterpret ambiguous country-specific regulatory requirements, develop organizational positions in areas of uncertainty, and influence decision-making to reduce regulatory risk while enabling business growth. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
Daiichi Sankyo, Inc.Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
CSL SeqirusNewAssociate Director, US Brand Marketing CSL SeqirusAssociate Director, US Brand MarketingSummit, NJ$180,000–$205,000With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Daiichi Sankyo, Inc.Associate Director, Public Policy Daiichi Sankyo, Inc.Associate Director, Public PolicyBasking Ridge, NJ$175,440–$263,160 / yearFull timeThis role will influence the external policy landscape so the value of Daiichi Sankyo's pipeline, portfolio, and business is protected and enhanced – allowing Daiichi Sankyo to continue bringing innovative medicines to patients who need them. Leverage subject matter expertise to assess potential policy implications to Daiichi Sankyo with internal stakeholders (e.g., Market Access, Regulatory Intelligence, etc.), develop DSI policy strategies and shape policy reform.
Clinical Dynamix, Inc.NewExecutive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe 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.
JouléNewAssociate Director Corporate Communications JouléAssociate Director Corporate CommunicationsParsippany, NJ$135,000–$170,000 / yearJoin a growing biopharmaceutical organization where communications plays a critical role in shaping corporate reputation, supporting key business milestones, and translating complex science into meaningful stories. This is an opportunity to work closely with executive leadership and cross-functional teams to drive both external and internal communications initiatives across a fast-paced, highly visible environment.
Daiichi Sankyo, Inc.Assistant General Counsel Commercial Daiichi Sankyo, Inc.Assistant General Counsel CommercialBasking Ridge, NJ$228,160–$342,240 / yearFull timeWork in an exciting and challenging legal environment by independently providing innovative and strategic legal support and solutions as a brand attorney and the primary legal advisor for the commercial business and operations supporting U.S. approved (or to be approved) oncology products and to specific assigned business functions in the Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs, Sales, Marketing, etc.) including, but not limited to, areas of vendor agreements, legal, business and regulatory issues. 7 or More Years pharmaceutical industry experience, particularly supporting specific assigned products and business areas in contracting, general legal advice, policy development and/or review, etc. in specific business support functions in an in-house capacity, as a legal consultant, and/or at a law firm in a practice group focusing on pharmaceutical industry and/or specific corporate business functions preferred .
JouléNewMedical Science Director JouléMedical Science DirectorParsippany, NJRemote$200,000–$235,000 / yearA field-based Medical Science Director will support Medical Affairs through compliant scientific exchange, insight gathering, and cross-functional collaboration across oncology and related therapeutic areas (infectious disease, nephrology, acute/critical care). This role partners with HCPs/KOLs, pharmacy leaders, and institutional stakeholders across inpatient/outpatient settings to support medical strategy, evidence generation initiatives, and scientific engagement (congresses, advisory boards, education).
AtriumNewSenior Commercial Counsel AtriumSenior Commercial CounselPrinceton, NJThis Senior Commercial Counsel opportunity is ideal for an Attorney who has experience supporting branded pharmaceutical launches within biotech or specialty pharma environments and who thrives in a highly collaborative business-facing role. Our client, a rapidly growing specialty biopharmaceutical organization, is seeking a Senior Commercial Counsel to support a late-stage pipeline focused on complex and underserved disease areas.
Dassault SystèmesNewVP Professional Services, Study Experience Dassault SystèmesVP Professional Services, Study ExperienceIselin, NJ$216,000–$288,000 / yearCelebrating 25 years of ground-breaking technological innovation across more than 36,000 trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. Experience: A minimum of 15 years of progressive experience in professional services, client services, or clinical operations within the life sciences industry (e.g., at a CRO, eClinical/SaaS vendor, Pharma, or Biotech).
Our House, Inc.NewFacilities Coordinator Our House, Inc.Facilities CoordinatorMurray Hill, NJRemoteWe are seeking a Facilities Coordinator to support the day-to-day operations of our residential properties and administrative locations while helping ensure our environments remain safe, compliant, organized, and well-maintained. This is a hands-on, fast-paced role that requires strong communication, problem-solving, and organizational skills while balancing multiple operational priorities across various sites.
IntelliPro Group Inc.Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJThis 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.
Eikon Therapeutics IncNewDirector, Regulatory Affairs Eikon Therapeutics IncDirector, Regulatory AffairsJersey City, NJ$213,000–$232,750 / yearThis role will report to a Senior Director, Regulatory Affairs, and requires a minimum of 3 days per week onsite (or more as business needs require) in our Jersey City, NJ, office to support effective cross-functional collaboration, operational excellence, and the evolving needs of our clinical development programs. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Lupin LtdSenior Director, Regulatory Affairs Lupin LtdSenior Director, Regulatory AffairsSomerset, NJThe Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupins complex portfolio, with a robust execution skill set. This role should also have the capability to implement 505b (2) strategies and submissions, a strong communication strategy with the FDA, and additional strong expertise in the Medical Device area, and the ability to understand the PK/PD strategy.
Abacus Service CorporationHiring Regulatory Affairs Associate II (Hybrid Remote) Abacus Service CorporationHiring Regulatory Affairs Associate II (Hybrid Remote)Princeton, NJRemoteEnsures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Typical activities may include work at a computer, copying, scanning, filing and, dependent on the position, considerable time may be spent sitting, standing or walking.
Stark Pharma Solutions IncNewRegulatory Affairs Associate Stark Pharma Solutions IncRegulatory Affairs AssociatePiscataway, NJWe are seeking a detail-oriented Regulatory Affairs Associate to support regulatory activities for medical devices, pharmaceuticals, biotechnology products, or combination products. Hi, My name is Karthik Mutyala, and I am a Recruitment Manager with Stark Pharma Solutions, specializing in opportunities across the Pharmaceutical, Biotechnology, Medical Device, and Life Sciences industries.
Aequor Technologies LLCRegulatory Affairs Associate II Aequor Technologies LLCRegulatory Affairs Associate IIPrinceton, NJMajor Accountabilities: To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
Apidel TechnologiesRegulatory Affairs Associate II Apidel TechnologiesRegulatory Affairs Associate IIPrinceton, NJContractorEnsures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Typical activities may include work at a computer, copying, scanning, filing and, dependent on the position, considerable time may be spent sitting, standing or walking.
Bristol Myers SquibbDirector, Early Precision Medicine Regulatory Affairs Bristol Myers SquibbDirector, Early Precision Medicine Regulatory AffairsPrinceton, NJ$244,110–$295,806 / yearServe as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies—enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time. Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review—ensuring diverse expertise is integrated to drive precision medicine innovation.
LancesoftRegulatory Affairs Associate II LancesoftRegulatory Affairs Associate IIPrinceton, NJ$50Major Accountabilities: To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
GenmabAssociate Director, Global Regulatory Affairs, Advertising & Promotion GenmabAssociate Director, Global Regulatory Affairs, Advertising & PromotionPrinceton, NJFull timeFor 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.
Judge GroupDirector, Regulatory Affairs Strategy Judge GroupDirector, Regulatory Affairs StrategyWarren, NJ$190,000–$220,000 / yearThis individual serves as the regulatory affairs main contact to project teams, providing leadership across functions for regulatory strategic planning and execution related to achieving program milestones. By providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes.
SystimmuneDirector/Sr. Director/Executive Director, Clinical Regulatory Affairs SystimmuneDirector/Sr. Director/Executive Director, Clinical Regulatory AffairsPrinceton, NJFull timeThe Regulatory Affairs (Clinical/Nonclinical) role will drive regulatory strategy and execution within SI Project development teams and the RA Department in all aspects of global regulatory affairs related to development of novel oncology therapeutics (multiple modalities such as ADCs, bispecific antibodies and T-cell engagers etc.). Own/drive the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: BLA/INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure.
Sun Pharmaceutical Industries LtdSenior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - Hybrid Sun Pharmaceutical Industries LtdSenior Director, Regulatory Advertising & Promotion, Medical Affairs, Princeton, NJ - HybridPrinceton, NJ$188,500–$230,000 / yearResponsibilities: • Provide regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area • Provide solution oriented and innovative advice to meet the Companys objectives and goals • Provide strategic advice for the development of Promotion advisory submissions • Ensure full regulatory compliance of all promotions with approved labeling and/or FDA guidance • Continuously monitor and maintain knowledge of the evolving regulatory landscape to provide innovative solutions and advice • Pursues and understands diverse perspectives inside and outside Sun Pharma to provide risk assessment and mitigation strategies • Develop and maintain strong working relationships with internal customers, including Commercial, Medical, Legal and Compliance • Integrate compliance considerations into risk assessment by partnering with Legal/Compliance colleagues • Provide advice and guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based • Provide input on process improvement as needed • Engages with colleagues within the department to help support them in their roles and development • Provide direct management to individuals depending on assignment • Proactively seeks opportunities to learn and develop leadership skills. Education & Qualifications: Education Required: Advanced degree (MS, PhD, PharmD, or JD) Minimum of 5-10 years Regulatory promotional review or 8 to 10 years of related pharmaceutical experience (e.g., Medical promotional review) Experience providing risk assessment to interdisciplinary teams on promotional materials and activities for marketed products and strong interest in FDA advertising and promotion regulations including guidance(s) Strong understanding of FDA regulations (OPDP/CBER) Ability to propose regulatory strategies for advertising and promotion campaigns, disease awareness, and institutional campaigns Proven aptitude to analyze and interpret efficacy and safety data Represents Ad/Promo at labeling meetings and provides strategic regulatory guidance Organizational skills and ability to pay attention to details Demonstrated ability to negotiate and influence others to help build team collaboration Excellent verbal, communication, and presentation skills Manage, oversee, and review the work of one or more direct reports Mentors Ad/Promo and cross-functional team members as needed.
Tris Pharma IncSpecialist, Regulatory Affairs Advertising & Promotion Review Tris Pharma IncSpecialist, Regulatory Affairs Advertising & Promotion ReviewMonmouth Junction, NJ$100,000–$140,000 / yearLeads regulatory reviews of external communications intended for healthcare professionals (HCPs), patients and caregivers, ensuring high-quality, accurate and compliant content aligned with US laws, Food and Drug Administration (FDA) regulations and guidance, Pharmaceutical Research and Manufacturers of America (PhRMA) principles and company policies. Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs.
Taiho OncologySpecialist, Regulatory Affairs Operations Publishing Taiho OncologySpecialist, Regulatory Affairs Operations PublishingPrinceton, NJ$86,700–$102,000 / yearFull timeThe Regulatory Affairs Operations team creates and manages investigational and marketing applications to health authorities like the FDA and EMA, compiles required data and maintains compliance with evolving regulations and technologies—including AI—to support drug review, approval and market access while protecting public health. Advanced skills in eCTD publishing tools (including docuBridge), MS-Office, Adobe Acrobat applications, electronic document management systems (preferably Generis’ CARA), and the ability to learn required systems and processes quickly.
EssenlixSenior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k) EssenlixSenior Regulatory Affairs & Quality Systems Manager - IVD / FDA 510(k)Monmouth Junction, New JerseyEssenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC) diagnostic systems, including hematology analyzers and disposable cartridges for complete blood count (CBC) testing. We are seeking an experienced Senior Regulatory Affairs & Quality Systems Manager to lead FDA 510(k) and CLIA submissions and global quality system development.
ImmunityBio IncRegulatory Affairs Program Manager ImmunityBio IncRegulatory Affairs Program ManagerSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. 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.
LancesoftNewRegulatory Affairs Senior Manager LancesoftRegulatory Affairs Senior ManagerWarren, NJJob Purpose: The purpose of this role is to execute OTC regulatory activities for new product registrations and life-cycle Maintenance for the portfolio of products defined by the US Business Units. Provides advice on US-specific activities and ways of working and processes; Proactively identify potential risks and manage impact of regulatory changes within defined scope of.
Pacira Pharmaceuticals, Inc.Senior Director, Regulatory Affairs Advertising, Promotion, & Labeling Pacira Pharmaceuticals, Inc.Senior Director, Regulatory Affairs Advertising, Promotion, & LabelingParsippany, New JerseyEstablish and oversee formal processes to provide regulatory support in the development, revision, review, and approval of labeling content for submission to Health Authorities (USPI, EU PI, and ROW labeling, as well as the internal Company Core Data Sheet). The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
TechDigital CorporationC08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALIST TechDigital CorporationC08 - MEDICAL AND REGULATORY AFFAIRS / PHARMACOVIG - PHARMACOVIGILANCE SPECIALISTTrenton, NJThe PV Analytics and Reporting Specialist, PV Analytics Center of Excellence contributes to the ongoing development, implementation, and successful execution of the scientific, operational, and regulatory reporting efforts in line with the overall WWPS needs. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across WWPS.
Gan & Lee PharmaceuticalsManagerSr. Manager - Regulatory Affairs Gan & Lee PharmaceuticalsManagerSr. Manager - Regulatory AffairsBridgewater, NJFull timeSupport agency interactions, including appropriate documentation of interaction, decisions and outcomes; contribute to the development of meeting requests, briefing documents and other supporting materialArchive management for related projects including submission archive and tracking submission/approval dates and Health Authorities correspondences. This position reports to the Functional Area Head, Global Regulatory Affairs and will be responsible for supporting the development and implementation of regulatory strategies, working closely with the cross functional teams to prepare, review and submit regulatory documents, manage documentation systems and maintain interactions with regulatory agencies.
TechDigital CorporationMedical and Regulatory Affairs - Medical Scientist TechDigital CorporationMedical and Regulatory Affairs - Medical ScientistTrenton, NJUnder the direct mentorship of the GI Tumor Leads, develop understanding of the assigned tumors and medical strategies, provide strategic input to a broad range of stakeholders, and facilitate strategic alignment. The primary responsibility of Medical Scientist is to support GI medical and tumor leads in translating medical strategies into tactical plans and leading the execution of these plans for assigned tumor(s).
Lancesoft IncPatient Recruitment Specialist Lancesoft IncPatient Recruitment SpecialistTrenton, NJ$55–$63 / hourDesign and implement comprehensive patient recruitment strategies at the protocol level, leveraging a broad mix of tactics, including partnerships with patient advocacy groups, recruitment vendors, digital solutions to enhance trial awareness, enrollment, and participant experience in alignment with overarching trial goals and timelines. This role will work cross-functionally with Clinical Operations, Global Development, Medical Affairs, Patient Advocacy, and external partners to deliver tailored recruitment solutions that address study-specific needs while supporting enterprise-wide objectives.
PSEGExternal Affairs Support Specialist PSEGExternal Affairs Support SpecialistTrenton, NJ$79,400–$125,600 / yearIf applicable, the successful applicant must prove they are: (1) a citizen or national of the USA; OR (2) a lawful permanent resident of the United States (Non-Conditional Permanent I-551 / Green Card / Permanent Resident Card holder); OR (3) a citizen, national, or permanent resident of a “Generally Authorized” destination on the attached list (https://corporate.pseg.com/-/media/PSEG/Corporate/Careers/Careers + Manage and execute department functions including employee onboarding and off-boarding, asset tracking, records management, purchase requisitions and order management, invoice verification and processing, internal reports, preparing PowerPoint and excel spreadsheets in order to support department operations.
Bristol Myers SquibbDirector, US Medical Affairs, Multiple Myeloma Bristol Myers SquibbDirector, US Medical Affairs, Multiple MyelomaMadison, NJ$207,490–$251,433 / yearThis individual will be involved in integrated strategic planning within Global Medical Affairs under the direction of the US Medical Multiple Myeloma lead and Global Multiple Myeloma disease lead as well as in close partnership with the US Commercialization organization, Clinical Research and Development, HEOR, Market Access, Translational Development, and Regulatory, and will lead the US Medical asset strategy supporting the US and Global Multiple Myeloma Disease Leads. Provide high quality clinical input and review of congress abstracts, posters, presentation slides, manuscripts, educational materials, steering committee and advisory board meeting materials, medical information response documents, scientific educational grant requests, compassionate use requests, and patient advocacy grant requests among others.
Johnson & JohnsonSenior Director, Strategic Therapeutic Area Lead, Autoantibody Pipeline, US Medical Affairs- Immunology Johnson & JohnsonSenior Director, Strategic Therapeutic Area Lead, Autoantibody Pipeline, US Medical Affairs- ImmunologyHorsham, PAActively contribute as a disease-specific TA subject matter expert and manage expertise on to provide advice and input to and support the Global Medical Affairs, R&D, Marketing, Sales, Market Access, New Business Development, Real World Value & Evidence, autoantibody MSL, Medical Information and Communications teams, shaping and influencing the collective strategy based on sound scientific principles, available data, and strategic insights. Responsibilities: Leading a team of multiple AAb Medical Affairs team direct reports in developing a scientifically, strategically, and competitively strong strategy(s) around pre-launch support and related activities, including HCP and expert/opinion leader engagement, which are anticipated to require substantial effort in developing strategy for new indications which are anticipated to be First-in-Disease approved therapies.
Acrotech Biopharma IncDirector, Medical Affairs - Dermatology Acrotech Biopharma IncDirector, Medical Affairs - DermatologyEast Windsor, New Jersey$190,000–$230,000 / yearPhysical Requirements: OFFICE POSITION - While performing the duties of this job the employee is required to: •Stand, sit; talk, hear, and use hands and fingers to operate a computer and telephone keyboard reach, stoop kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). Job Overview: Lead the Dermatology US Medical Affairs team, as a valued strategic partner with Clinical, Commercial, and Marketing teams to bring innovative therapeutic solutions to improve the lives of patients and establish Acrotech as a leader in atopic dermatitis.
YANTRAN LLCResearch & Development, Scientist 2 YANTRAN LLCResearch & Development, Scientist 2Summit, NJ$30–$35 / yearFull timeWork closely with cross-functional teams, including other R&D functions, Commercial Marketing, Quality Assurance, Regulatory Affairs, and Manufacturing, to achieve project goals. Prepare and maintain detailed documentation for product development processes, including experimental protocols, and technical reports in compliance with Good Documentation Practices (GDP).