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.
EHS, QMS & Regulatory Specialist Synerfac Technical StaffingEHS, QMS & Regulatory SpecialistCarlstadt, NJNice 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.
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.
NewMedical Science Liaison, Hematology - Northeast Jazz PharmaceuticalsMedical Science Liaison, Hematology - NortheastNew York, NYRemote$160,000–$240,000 / yearThe successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. Consistently acts to enhance Jazz Pharmaceuticals’ image as an advocate of medical advancement by using knowledge of product, disease state and pipeline products to engage healthcare providers in meaningful scientific exchange of information.
NewRecords and Information Specialist ECLARORecords and Information SpecialistWHITE PLAINS, NY$1 / hourThe Records Assistant role supports the Corporate Records team by reviewing, preparing, digitizing, and classifying hardcopy documents for inclusion in the organization's Records Management System. Work in accordance with client's records and content management policies Under the supervision of Digital warehouse and the Law department, assist in the creation of a digital collection for archived hard copy law cases.
NewAquestive District Sales Manager Inizio EngageAquestive District Sales ManagerEdison, NJ$180,000–$210,000 / yearConnect daily sales activities to the broader mission—helping representatives see how their work removes barriers for patients who need an effective, easy-to-carry, easy-to-use epinephrine rescue medication. This isn't management from a distance; you'll be in the field coaching your territory representatives through complex sales cycles, celebrating breakthrough moments, and holding the line on performance and integrity.
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.
Sr. Director, Global Brand & Portfolio Management CSLSr. Director, Global Brand & Portfolio ManagementSummit, NJ$287,000–$352,000 / yearOversees and guides continued global launch planning for aTIVc, including maximizing the portfolio opportunity across Fluad and aTIVc, refining the launch sequencing strategy, advancing business cases for key investments, and leveraging the Glocal brand marketing model (global to local division of activities) to drive efficiencies. Working in close partnership with R&D and cross-functional stakeholders, the role ensures alignment from research through commercialization, advances high-value strategic investments, and drives portfolio decisions that maximize mid- to long-term growth, value creation, and public health impact.
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.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineRahway, NJ$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Regulatory Affairs Associate I IntelliPro Group Inc.Regulatory Affairs Associate IClark, NJ$30–$36 / hourThis 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.
Program Development Analyst (Regulatory Affairs Associate) Actalent IncProgram Development Analyst (Regulatory Affairs Associate)New Brunswick, NJRemote$35–$40 / hourThis position involves working closely with various stakeholders, including investigators, network staff, industry sponsors, and regulatory bodies, to streamline protocol approvals and maintain comprehensive regulatory documentation. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Senior Manager, Regulatory Affairs, CMC Shionogi & Co LtdSenior Manager, Regulatory Affairs, CMCFlorham Park, NJ$140,000–$170,000 / yearDemonstrated ability to collaborate effectively with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to achieve regulatory milestones and drive product development initiatives forward. Work closely with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Commercial teams, to ensure alignment of CMC regulatory requirements with overall product development plans and timelines.
Regulatory Affairs Intern Phibro Animal Health CorpRegulatory Affairs InternTeaneck, NJPhibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.
Associate Director, Regulatory Affairs - CMC BridgeBio Pharma IncAssociate Director, Regulatory Affairs - CMCNY$190,000–$235,000 / yearIn conjunction with regulatory affairs leadership, he/she will develop strong relationships, collaborate, and interact with various departments and levels of management, including interactions across BridgeBio subsidiaries. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process.
Senior Specialist, Regulatory Affairs ImmunityBioSenior Specialist, Regulatory AffairsSummit, NJDesignated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. 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.
Regulatory Affairs Specialist OrganOxRegulatory Affairs SpecialistMadison, NJ$120,000–$135,000 / yearThe role works closely with Regulatory Affairs team members responsible for software, hardware, disposable products, labelling, and other regulatory disciplines to support submission activities, maintain accurate regulatory records, and ensure alignment across product areas and markets. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant.
Sr. Regulatory Affairs Specialist VB Spine LLCSr. Regulatory Affairs SpecialistAllendale, NJ$100,000–$105,000 / yearAs a Senior Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. At VB Spine, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for continued growth in a dynamic, mission-driven medical device company.
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.