NewRecords & Information Specialist ECLARORecords & Information SpecialistWhite Plains, NYPosition Overview: The Records & Information Specialist role supports the Corporate Records team by reviewing, preparing, digitizing, and classifying hardcopy documents for inclusion in the organization's Records Management System. Familiarity working with a Records Retention Schedule by associating documents with their Record Series Titles, retention periods, regulations, and RM File Numbers.
NewAnalytical Science Manager JouléAnalytical Science ManagerParsippany, NJ$100,000–$135,000 / yearSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. Partner with Quality Assurance, Regulatory Affairs, and external test sites to support technology transfers, and analytical method validations.
NewDirector Corporate Communications JouléDirector Corporate CommunicationsParsippany, NJ$170,000–$200,000 / yearThe Director will shape corporate storytelling, executive communications, media relations, employee engagement, and digital strategy while translating complex scientific and clinical information into clear, compelling messaging. This is an opportunity to take ownership of corporate communications for a growing, publicly traded biopharmaceutical company and work closely with executive leadership on high visibility initiatives.
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.
Regulatory Affairs Associate Director, Globalization (Registrations) Becton Dickinson and CoRegulatory Affairs Associate Director, Globalization (Registrations)Franklin Lakes, NJ$183,800–$294,100 / yearProblem 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 and create effective and innovative solutions. Provide centralized regulatory intelligence and governance related to global product registration to interpret and execute on global regulatory requirements, ensuring timely insight and clear guidance to Business Units and Regions to enable compliant growth and market access.
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 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.
Senior 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.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron PharmaceuticalsManager, 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 Regulatory Affairs Specialist iRhythm Holdings IncSenior Regulatory Affairs SpecialistNYRemote$99,000–$129,000 / yearAs a remote Senior Regulatory Affairs Specialist with a fast growing, AI software and wearable hardware medical device company, you will be responsible for working with cross functional teams to assess market requirements, develop global product registration strategies, help guide project teams from preparation to submission and through successful dossier reviews with various regulatory agencies to gain and maintain product registrations. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address.
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 - Quality & Regulatory Affairs EnvistaManager - Quality & Regulatory AffairsMahwah, NJEnvista 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.
Compliance Manager, Licensing & Regulatory Affairs Felix TechnologiesCompliance Manager, Licensing & Regulatory AffairsNew York, New YorkWe are a hyper-growth Series C company, backed by over $200 million in funding from top-tier global investors, including QED, Castle Island, Switch Ventures, HTwenty, Monashees, and Andreessen Horowitz with support from General Catalyst Customer Value Fund. This individual will own the day-to-day management of Felix’s licensing portfolio, support expansion into new jurisdictions and products, and serve as the primary coordinator for regulator communications, examinations, and licensing-related projects.
Associate Director/Director, Regulatory Affairs Advertising & Promotions Tris PharmaAssociate Director/Director, Regulatory Affairs Advertising & PromotionsMonmouth Junction, NJ$160,000–$180,000 / yearTris Pharma, Inc. (www.trispharma.com) is a leading privately-owned US biopharmaceutical company focused on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. Associate Director- PhD or PharmD in life sciences, pharmacy, medicine or a related discipline and minimum 3 years' experience as a regulatory reviewer of advertising and promotional materials in the pharmaceutical, biotechnology or related industry REQUIRED.
Director, 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.
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.
Director, Head of Markets Regulatory Affairs & Registrations (U.S. Broker-Dealer) Mitsubishi UFJ Financial GroupDirector, Head of Markets Regulatory Affairs & Registrations (U.S. Broker-Dealer)New York, New YorkAdditionally, our Total Rewards program provides colleagues with a competitive benefits package (in accordance with the eligibility requirements and respective terms of each) that includes comprehensive health and wellness benefits, retirement plans, educational assistance and training programs, income replacement for qualified employees with disabilities, paid maternity and parental bonding leave, and paid vacation, sick days, and holidays. Operating within the Compliance function and the Three Lines of Defense framework, the role serves as a trusted advisor to senior leadership and is responsible for driving regulatory readiness, enhancing governance practices, and promoting a culture of accountability, transparency, and continuous improvement across the U.S. broker-dealer environment.
Executive Director, Regulatory Affairs - Global Regulatory Leader Summit Therapeutics IncExecutive Director, Regulatory Affairs - Global Regulatory LeaderNY$231,000–$285,000 / yearOverview of Role: The Executive Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications (BLA/MAA) for product(s) in the oncology therapeutic area. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.