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.
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.
LaGuardia Community CollegeCREAR Futuros Program Coordinator (Academic Program Coordinator) LaGuardia Community CollegeCREAR Futuros Program Coordinator (Academic Program Coordinator)Long Island City, NY$48,647–$59,444 / yearFull timeCREAR (College Readiness, Achievement, and Retention) Futuros—meaning “to create futures”—is a national, Hispanic Federation–powered peer mentorship initiative designed to promote college access, retention, academic success, leadership development, and graduation among Latinx students, while remaining open to all eligible students regardless of background. At LaGuardia Community College, CREAR Futuros is housed within Casa de las Américas, a student-centered cultural and academic hub advancing the educational, professional, and leadership development of Latinx, Latin American, and Caribbean students through high-impact and culturally informed programming.
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/.
JobotNewVice President Clinical Development Ophthalmology JobotVice President Clinical Development OphthalmologyHoboken, NJ$350,000–$400,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development.
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.
Goldman Sachs & Co. LLCNewAssociate, Banker - Industry/Country Coverage Goldman Sachs & Co. LLCAssociate, Banker - Industry/Country CoverageNew York, NY$175,000–$225,000 / yearPrior experience must include one (1) year of experience with Master’s degree or three (3) years of experience with Bachelor’s degree with: Producing client reports using market data analyses, leveraging electronic data sources including Bloomberg, FactSet, or Capital IQ; performing credit analysis, including analyzing a company’s financial position, evaluating historical cashflow, assessing the maturity profile; analyzing company data, including strategic operating plans, documentation of live transactions, and regulatory filings; executing debt and equity or private M&A (buyside and sell-side) transactions; and Liaising with capital market specialists in connection with the structuring, pricing and distribution of structure. Requires: Master’s degree (U.S. or foreign equivalent) in Finance, Economics, Business Administration, International Affairs, or a related field and one (1) year of experience in the job offered or in a related role OR Bachelor’s degree (U.S. or foreign equivalent) in Finance, Economics, Business Administration, International Affairs, or a related field and three (3) years of experience in the job offered or in a related role.
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.
JobotNewTransactional Construction Associate Attorney JobotTransactional Construction Associate AttorneyNew York, NY$180,000–$350,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. We are a leading AM 100 Law Firm specializing in corporate and business law, complex litigation, intellectual property, regulatory matters, and government affairs and employing some of the best and brightest attorneys.
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).
City National BankNewCompliance Specialist Senior Wealth Management City National BankCompliance Specialist Senior Wealth ManagementNew York, NYRemote$85,000–$145,000 / yearFunctions as an internal consultant to colleagues throughout City National Bank (CNB) related to operational compliance issues and concerns, utilizing their internal and external organizational agility to ascertain and deliver sound interpretation and advice. Benefits and PerksAt City National, we strive to be the best at whatever we do, including the benefits and perks we offer our colleagues including:Comprehensive healthcare coverage, including Medical, Dental and Vision plans, available the first of the month following start date.
City National BankNewHead of Wealth Management Compliance City National Bank City National BankHead of Wealth Management Compliance City National BankNew York, NYRemote$200,000–$340,000 / yearAdvanced knowledge of the Investment Advisers Act of 1940, the Investment Company Act of 1940, the Securities Act of 1933, and Securities Exchange Act of 1934 is required, with knowledge of bank non-deposit investment product requirements, OCC Regulation 9, and ERISA regulations. Advance compliance programs that focus on regulatory requirements across applicable regulatory regimes, including: the Investment Advisers Act of 1940, the Investment Company Act of 1940, the Securities Act of 1933, Securities Exchange Act of 1934, and OCC Regulation 9.
Vaco LLCNewTalent Acquisition Specialist Vaco LLCTalent Acquisition SpecialistNew York, NY$35–$41This position will primarily support hiring for Resource Development, Marketing, and Communications teams, including roles within Development/Fundraising, Public Affairs, Corporate Communications, and Marketing & Communications. Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs.
Physician Affiliate Group of New YorkNewAssociate Director, Patient Safety and Risk Management - NYC Health + Hospitals/Kings County - Brooklyn, New York Physician Affiliate Group of New YorkAssociate Director, Patient Safety and Risk Management - NYC Health + Hospitals/Kings County - Brooklyn, New YorkBrooklyn, NYPAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Located in the heart of Brooklyn, Kings County Hospital accommodates more than 518,076 outpatient visits, more than 141,328 emergency room visits, 627 beds, and more than 25,000 inpatient admissions annually.
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.
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.
Oscar HealthSenior Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / yearManage the end-to-end administrative lifecycle of each dispute by maintaining real-time updates on project management boards, gathering and redacting member documentation, and uploading supporting evidence to the appropriate portal stages within set regulatory deadlines. Work Location: This is a remote position, open to candidates who reside in: Arizona, Florida, Georgia, Illinois, Iowa, Kansas, Michigan, Missouri, Nebraska, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Virginia.
Axsome TherapeuticsAssociate Director/Director, Regulatory Affairs Axsome TherapeuticsAssociate Director/Director, Regulatory AffairsNew York City, NYRemote$160,000–$215,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members.
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.
JPMorgan Chase Bank, N.A.Associate, Regulatory Affairs - Global Government Relations JPMorgan Chase Bank, N.A.Associate, Regulatory Affairs - Global Government RelationsNew York, NYFull timeAs the public policy environment globally is evolving rapidly due to technological change and a desire by policymakers to drive economic growth and international competitiveness, you will provide support to the CIB Regulatory Affairs team in responding to this dynamic environment and feed into the firm's advocacy, engagement, and strategic responses on key regulatory policy issues. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management.
Credit Agricole SADirector - Compliance Coordination and Regulatory Affairs Credit Agricole SADirector - Compliance Coordination and Regulatory AffairsNEW YORK, NY$190,000–$240,000 / yearThe Director- Compliance Coordination and Regulatory Affairs is a senior role within the Compliance Team responsible for the following functions:Regulatory Engagement & Examination ManagementServe as Compliance primary point of contact for U.S. regulatory agencies during examinations, inquiries, and ongoing supervisory activities;Coordinate and manage end-to-end regulatory examinations, including preparation, document production, regulatory meetings, and remediation efforts;Develop and maintain examination response protocols and methodology;Track and manage regulatory requests to ensure timely, accurate, and complete responses;Review and challenge regulatory deliverables;Support regulatory inquiries and examinations in the Americas and across business lines as needed;Internal Audit CoordinationPartner with Internal Audit to coordinate compliance-related audit reviews;Manage audit response processes, including deliverables validation and review;Strategic Project LeadershipLead and contribute to high-priority compliance projects and department-wide initiatives;Collaborate with cross-functional teams to implement compliance program enhancements;Drive process improvements and automation opportunities within the compliance function;Stakeholder ManagementBuild and maintain productive relationships with regulatory agencies;Partner with other divisions (business lines/support functions) on compliance matters;Provide regular updates to senior leadership on regulatory developments and examination status. This team has a number of different functions, but its primary functions are the management of interactions with US Regulators, management of compliance projects, tracking and reporting of issues, quality assurance, regulatory watch and support to regulatory changes, compliance communication, and regulatory coordination.
The Hain Celestial Group IncSr. Associate Regulatory Affairs The Hain Celestial Group IncSr. Associate Regulatory AffairsHoboken, NJRemoteRole Purpose The Senior Associate Regulatory Affairs is responsible for ensuring that all products labels and marketing claims comply with applicable regulatory requirements across domestic and international markets. This role supports product innovation and commercialization by providing regulatory guidance, managing submissions, and partnering cross-functionally to mitigate compliance risk while enabling speed to market.
EnergyHubManager, Policy and Regulatory Affairs EnergyHubManager, Policy and Regulatory AffairsBrooklyn, NY$100,000–$125,000 / yearPrioritize the highest-leverage advocacy opportunities and initiatives related to grid modernization, integrated resource planning, demand-side management, transportation electrification, energy storage, rate cases, state and federal legislation and grant programs, etc. Work with the latest technologies: You'll gain exposure to a broad spectrum of IoT, SaaS and machine learning obstacles, including distributed fault-tolerance, device control optimization, and process modeling to support scalable interaction with disparate downstream APIs.
Becton Dickinson and CoNewRegulatory Affairs Senior Manager, Globalization Becton Dickinson and CoRegulatory Affairs Senior Manager, GlobalizationFranklin Lakes, NJ$172,000–$275,200 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of assigned projects, enlisting resources to efficiently meet project needs. Problem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make thorough regulatory assessments demonstrating the ability to solve difficult problems.
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.
Macpower Digital Assets Edge Private LimitedRegulatory Affairs Manager Macpower Digital Assets Edge Private LimitedRegulatory Affairs ManagerNew York, NY$43–$55 / hourSummary: The Regulatory Affairs Manager ensures regulatory compliance of The Avon/LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
Bank of China Limited, New York BranchLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of China Limited, New York BranchLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearOversee all facets of compliance-related regulatory exams, as well as additional exams covering other Independent Risk Management (IRM) functions, such as Operational Risk Management, etc., as requested by CRO; manage exam requests, meeting preparation and presentation, exam logistics, and communication of exam deadlines and updates to relevant parties, and Senior and Executive Management; and ensure efficient, effective and accurate communication between regulators and the Bank. The VP establishes and maintains RAO policies/procedures and oversees all Regulatory Affairs Matters, including project management, stakeholder relationships, and day-to-day processes, communication with regulators, tracking and coordinating regulatory deliverables, driving the submission process to ensure timely execution and quality assurance, and reporting regulatory updates to Bank Management and committees.
BeOne Medicines LtdSenior Director Regulatory Affairs, CMC BeOne Medicines LtdSenior Director Regulatory Affairs, CMCNY$204,500–$274,500 / yearProvide strategic and operational leadership for the development and execution of global biologics Regulatory CMC strategies for the responsible regions, including oversight of authoring, review, and lifecycle management of CMC sections of CTDs (Modules 2 and 3) for INDs, BLAs, MAAs, and post approval submissions. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs Manager Macpower Digital Assets Edge Private LimitedSenior Regulatory Affairs ManagerNew York, NY$90–$130 / hourThe Senior Regulatory Affairs Manager ensures regulatory compliance of The client / LG H&H US cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising.
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.
Vera TherapeuticsNewVice President, Regulatory Affairs Vera TherapeuticsVice President, Regulatory AffairsNew York, NY$259,000–$394,000 / yearVera Therapeutics' lead product candidate is atacicept, a fusion protein self‑administered at home as a subcutaneous once weekly injection that blocks both B‑cell Activating Factor (BAFF) and A Proliferation‑Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Lead or directly oversee global health authority interactions (e.g., FDA, EMA, PMDA and key national agencies), including scientific advice/protocol assistance, Type B/C meetings, pre‑submission and advisory committee preparations; ensure high‑quality briefing packages and robust meeting follow‑up.
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.
MercorRegulatory Affairs Expert - Fully Remote MercorRegulatory Affairs Expert - Fully RemoteNew York, New YorkRemote$1,150–$1,450Include design history files, regulatory submissions, DHF/DMR documents, risk-analysis matrices, validation protocols, CAPA records, and email threads. Task Completion Pay: Competitive and based on task quality (~$1,150–$1,450 per completed task).
BeOne Medicines LtdNewAssociate Director, AI Enablement (Commercial & Medical Affairs) BeOne Medicines LtdAssociate Director, AI Enablement (Commercial & Medical Affairs)$144,300–$194,300 / yearThis role will focus on engineering and operationalizing AI systems-including Retrieval-Augmented Generation (RAG), agentic AI frameworks, and LLM-powered services-enabling teams across Commercial, Medical, and other functions to build and deploy AI solutions in a secure, scalable, and reusable manner. As a key technology leader, you will define and drive the AI platform strategy, developer experience, and enablement frameworks, ensuring seamless integration with BeOne's modular technology stack (data platforms, CRM, marketing systems, and analytics environments).