EHS, QMS & Regulatory Specialist Synerfac Technical StaffingEHS, QMS & Regulatory SpecialistCarlstadt, NJ$70,000–$90,000 / yearYou'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. Nice 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.
NewCompliance 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. Working knowledge of OCC Retail Non-Deposit Investment Products (RNDIP), Regulation R, associated investment products and services including associated ERISA compliance requirements.
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.
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.
NewMedical Science Director (New England Region) JouléMedical Science Director (New England Region)Parsippany, 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).
Director, Content Marketing, Global Payment Network Discover Financial ServicesDirector, Content Marketing, Global Payment NetworkNew York, NY$206,000–$235,100 / yearStay close to the competitive landscape with a restless curiosity; tracking what the best content operations in financial services and beyond are doing, identifying where they fall short, and ensuring Global Payment Network leads rather than follows. Diners Club International is a premium issuing brand that has 40+ issuers in 35+ countries; the Diners Club network is an international network that provides global acceptance to cardholders of participating Issuers from around the world.
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.
NewSr. 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.
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 Associate Director, Global Regulatory Affairs CMC -NCE and/or NBE Boehringer IngelheimSenior Associate Director, Global Regulatory Affairs CMC -NCE and/or NBERidgefield, CT$170,000–$269,000 / yearIf you want to apply for the position in Germany , please use this link: Senior Regulatory Affairs Manager CMC for NBE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NBE-Germ/1271415301/) and/or Senior Regulatory Affairs Manager CMC for NCE Job Details | BoehringerPRD (https://jobs.boehringer-ingelheim.com/job/Biberach-Senior-Regulatory-Affairs-Manager-CMC-for-NCE-Germ/1271422201/). + Ensures that CMC regulatory requirements for variations are available in the change management system (Global Variation Database) and supports the CMC Change Coordinator in providing worldwide regulatory assessment of change applications, the Global Variation Database coordinator is responsible for the maintenance of the database.
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.
Director/Senior Associate Director, US Product Group Oncology Regulatory Affairs (Hybrid) Boehringer Ingelheim International GmbHDirector/Senior Associate Director, US Product Group Oncology Regulatory Affairs (Hybrid)Ridgefield, CT$170,000–$269,000 / yearProvides US strategic regulatory guidance and input to key internal development, registration and commercialization documents for assigned projects (e.g., development plans, protocols, clinical trial reports, pediatric development plans, core dossier elements, integrated brand plans, market access documents), with particular emphasis on the US contribution. The Director or Senior Associate Director, US Product Group Regulatory Affairs will proactively participate in US/global cross-functional meetings and discussions, ensuring that US regulatory considerations are incorporated timely and comprehensively at key inflection points and in the decision-making process.
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 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.
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.
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.
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.
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, 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.