Regulatory Affairs Strategist Aquestive Therapeutics Inc.Regulatory Affairs StrategistWarren, NJThis 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.
Chief Diversity Officer LaGuardia Community CollegeChief Diversity OfficerQueens, NY$131,440–$141,325 / yearFull timeLaGuardia ranked fifth among U.S. community colleges in economic mobility – moving low-income students into the middle class and beyond – in studies by Stanford University (2017) and the Brookings Institution (2020). Reporting to the President, the Chief Diversity Officer (CDO) is responsible for overseeing and managing the diversity and compliance staff, campus diversity and compliance initiatives, federal, state, and CUNY policies/regulations while maintaining the highest level of confidentiality and integrity with faculty, staff, and students.
Director, Healthcare Compliance Aquestive Therapeutics Inc.Director, Healthcare ComplianceWarren Twp, NJReporting 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.
Sales Training Senior Manager/Director Aquestive Therapeutics Inc.Sales Training Senior Manager/DirectorWarren, NJAs a key member of the commercial organization, this individual will be responsible for building a comprehensive learning curriculum that equips sales leaders and specialty sales representatives with the knowledge, skills, and behaviors necessary for launch success and growth. The Director will partner closely with Sales, Marketing, Medical Affairs, Market Access, Legal, Regulatory, Compliance, and external partners to translate commercial strategy into effective, compliant, and measurable learning experiences.
Director, Vaccine Portfolio Strategy & External Partnerships CSLDirector, Vaccine Portfolio Strategy & External PartnershipsSummit, NJ$222,000–$299,000 / yearStrategic thinking and commercial assessment expertise; ability to anticipate market shifts and create high-value deliverables from white space; strong pharmaceutical/vaccine commercialization knowledge, including lifecycle strategy, launch excellence, market access, pricing, business development, and strategic marketing frameworks; business case development, forecasting, market sizing, valuation, scenario planning, and investment prioritization capabilities; knowledge of AI and its application in R&D capabilities to assess potential opportunities, including evidence synthesis, target/product profile evaluation, development feasibility, assumption testing, scenario modeling, and risk identification; external-facing leadership with ability to guide commercial discussions, support negotiation strategy, and collaborate with Legal on CDA, MTA, services agreement, and related contracting processes; data-driven decision-making using clinical evidence, market research, competitive intelligence, policy, and regional insights; strong cross-functional leadership and ability to lead without authority; clear executive communication and stakeholder influence; executional excellence, prioritization, judgment, and learning agility. Partner with R&D inclusive of Research, Clinical Development and Medical affairs, Global Market Access & Pricing, Business planning, Manufacturing & Supply, Legal, and regions to evaluate strategic fit, commercial attractiveness, risk-adjusted value, implementation feasibility, and ensuring these inputs are appropriately reflected in portfolio assessments and business cases.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals IncManager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$128,600–$210,000 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Senior Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsSenior Manager, Regulatory Affairs, Advertising & PromotionSleepy Hollow, NY$150,500–$245,500 / yearHelp lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions. Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs.
Associate Director, Regulatory Affairs Nuvation Bio, Inc.Associate Director, Regulatory AffairsRemote - Any State US, NYRemote$190,000–$200,000 / yearWe are looking for an experienced hands-on Regulatory Affairs professional to contribute to the development strategy and lead in the planning, preparation, submission and maintenance of regulatory submissions for Nuvation products. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncAssociate Manager, Regulatory Affairs Strategy - OncologyTarrytown, NY$109,900–$179,300 / yearDiscover your role: Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Associate Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - OncologyTarrytown, NY$128,600–$210,000 / yearDiscover your role: Coordinate 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: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Regulatory Affairs Analyst Adults and Children with Learning and Disabilities IncRegulatory Affairs AnalystBethpage, NYProvide expert technical and consulting support, regarding OPWDD regulations, ACLD policies and procedures in regulatory affairs related programs and other complex related matters to the ACLD workforce. Assist in the training of all new management level staff to ensure consistency in training and orientation of new managers and administrators within assigned programs, i.e., personal needs allowance, etc.
Manager - Quality & Regulatory Affairs Envista DentistryManager - Quality & Regulatory AffairsMahwah, New JerseyEnvista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.
Sr. Director, Regulatory Affairs Eikon Therapeutics, Inc.Sr. Director, Regulatory AffairsJersey City, NJ$235,000–$288,750 / yearThis role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in our Jersey City (NJ) office to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. In this role, they will excel in developing and executing regulatory strategies, ensuring compliance, managing submissions, fostering cross-functional collaboration, liaising with regulatory agencies, supervising quality assurance, and addressing regulatory risks associated with projects.
Legal Counsel Of Corporate And Regulatory Affairs Atlantic Health SystemLegal Counsel Of Corporate And Regulatory AffairsMorristown, NJDraft, review, negotiate, and interpret a broad range of commercial agreements, including professional services agreements, physician and provider arrangements, purchasing and supply chain contracts, consulting agreements, confidentiality agreements, technology and software agreements, revenue-generating partnerships, and other operational contracts. As a member of a collaborative in-house legal department, Counsel will work closely with executive leadership, clinical and operational teams, compliance professionals, and business partners to develop practical legal solutions that advance innovation while ensuring regulatory compliance and protecting the organization's mission.
Legal Counsel of Corporate and Regulatory Affairs Atlantic Health System IncLegal Counsel of Corporate and Regulatory AffairsMorristown, NJDraft, review, negotiate, and interpret a broad range of commercial agreements, including professional services agreements, physician and provider arrangements, purchasing and supply chain contracts, consulting agreements, confidentiality agreements, technology and software agreements, revenue-generating partnerships, and other operational contracts. As a member of a collaborative in-house legal department, Counsel will work closely with executive leadership, clinical and operational teams, compliance professionals, and business partners to develop practical legal solutions that advance innovation while ensuring regulatory compliance and protecting the organization''s mission.
Medical Device Regulatory Affairs Strategist Oracle CorpMedical Device Regulatory Affairs StrategistNYRemote$87,000–$178,100 / yearAs a Principal/Lead/Senior Regulatory Affairs Specialist, you will work in collaboration with product engineering and development teams and subject matter experts on the total product lifecycle of AI-enabled, Cloud-native software applications used in clinical operation, clinical information systems, and clinical decision support (medical device and non-medical Device). About the Role: At a time when global technological developments and healthcare regulations are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in the public and private levers that impact this industry.
Associate Director Regulatory Affairs Advertising & Promotion - Eye Care Hybrid AbbVie IncAssociate Director Regulatory Affairs Advertising & Promotion - Eye Care HybridFlorham Park, NJApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines Perrigo Co PlcProfessional Regulatory Affairs - Lifecycle Management - Non-MedicinesMorristown, NJWe are excited to recruit a Regulatory Affairs Professional within Non-Medicinal Lifecycle Management, you will play an important role in supporting Perrigos non medicinal portfolio including cosmetics, VMS, general products and other non-medicinal classifications such as medical devices across the product lifecycle. You will be responsible for managing lifecycle management activities, including the preparation, maintenance and delivery of regulatory documentation, product information files, technical files, notifications, registrations and supporting records in line with global requirements and business priorities.
Regulatory Affairs Compliance Manager PBF Energy IncRegulatory Affairs Compliance ManagerParsippany, NJ$106,787.51–$189,503.19 / yearThis role includes day-to-day management of ISCC program requirements and risk management, continuous monitoring of regulatory and system updates, and direct accountability for mass balance, conversion factors, GHG calculations, and audit readiness and execution. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills and internal peer equity will be considered in determining the selected candidate's compensation.
NewRegulatory 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.