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.
Vice President Clinical Development Ophthalmology JobotVice President Clinical Development OphthalmologyNew York, NY$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.
Transactional 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.
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.
NewAssociate, 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.
NewTalent 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.
NewRegional Business Director Inizio EngageRegional Business DirectorNew York, NY$160,000–$200,000Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes. Inizio Engage is seeking a Regional Business Director to support Cristcot, an established pharmaceutical company with a proven track record in developing novel formulations and optimized drug-device systems, in preparing for a U.S. product launch in ulcerative colitis.
NewAssociate 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.
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.
Regulatory Affairs Associate Director, Globalization Becton Dickinson and CoRegulatory Affairs Associate Director, GlobalizationFranklin 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 Analyst, Regulatory Affairs Oscar Health IncSenior Analyst, Regulatory AffairsNew York, 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.
Regulatory Affairs Senior Director, Project Management Excellence Becton Dickinson and CoRegulatory Affairs Senior Director, Project Management ExcellenceFranklin Lakes, NJ$230,300–$368,500 / yearKnowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous 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 decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions.
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.
Senior Manager, Regulatory Affairs Quidelortho CorpSenior Manager, Regulatory AffairsNJRemoteThis position is remote eligible, with a strong preference for candidates who reside in Raritan, NJ; Rochester, NY; or Pompano Beach, FL The Responsibilities Reviewing and interpreting regulations/guidance documents to develop a regulatory strategy to support Transfusion Medicine project teams in terms of regulatory submission pathway, clinical efficacy requirements, predicate device selection, submission requirements, timing, and risks. The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.
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 Analyst, Regulatory Affairs Oscar HealthSenior Analyst, Regulatory AffairsNew York City, NYRemote$79,488–$104,328 / year
Senior Associate, Regulatory Affairs (US) BeOne Medicines AGSenior Associate, Regulatory Affairs (US)NY$40.91–$52.91 / hourAssist regulatory affairs team/strategist in supporting strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.
Associate Director, Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, Regulatory AffairsNew York, NYRemote$176,400–$207,500 / yearCreate and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. Powered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter faster, better, and at scale for patients who are waiting.
Senior International Regulatory Affairs Specialist Becton Dickinson and CoSenior International Regulatory Affairs SpecialistFranklin Lakes, NJ$110,200–$176,400 / yearFor most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Regulatory Affairs Senior Director, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Director, DigitalizationFranklin Lakes, NJ$230,300–$368,500 / yearThe Senior Director of Regulatory Affairs, Digitalization, reports to the Vice President of Regulatory Affairs, Regulatory Affairs Management, Enterprise Excellence, and is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions. Lead Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Assistant, or Associate Professor of Drug Regulatory Affairs Long Island UniversityAssistant, or Associate Professor of Drug Regulatory AffairsBrooklyn, NY$110,001–$120,000 / yearChair, Faculty Recruitment Committee, Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, New York at ahmed.abufayyad@liu.edu. Assistant, or Associate Professor of Drug Regulatory AffairsAssistant, or Associate Professor of Drug Regulatory Affairs No. 4129 Long Island University Brooklyn, New York Pharmaceutics and Indust Sci Posted Apr 17, 2026 $110,001-$120,000.
Regulatory Affairs Strategist, Digitalization Becton Dickinson and CoRegulatory Affairs Strategist, DigitalizationFranklin Lakes, NJ$137,500–$220,100 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
Regulatory Affairs Specialist, Digitalization Becton Dickinson and CoRegulatory Affairs Specialist, DigitalizationFranklin Lakes, NJ$110,200–$176,400 / yearProblem Solving, Analytical Skills and Professional Judgement: Uses a combination of logic, analysis, experience, wisdom, and advanced methods to make decisions and solve problems, demonstrating the ability to solve difficult problems and create effective and innovative solutions. Knowledge and Skills: Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of multiple simultaneous projects, enlisting resources to efficiently meet project needs.
Senior Director, Regulatory Affairs Strategy Immunovant IncSenior Director, Regulatory Affairs StrategyNew York, NY$270,000–$290,000 / yearThe Senior Director will provide deep regulatory expertise, lead health authority interactions, mentor regulatory leaders, and partner closely with cross-functional and Regulatory leadership to ensure consistent, high-quality regulatory strategies that support corporate objectives. Provide direct or matrix leadership to Regulatory Strategy personnel (e.g., Managers, Associate Directors, Directors), including coaching, mentoring, and development of future regulatory leaders.
Regulatory Affairs Admin Asst Life's WORCRegulatory Affairs Admin AsstGarden City, New YorkExcellent verbal & written communication skills, excellent organizational & time management skills, as well as excellent customer service skills. Assist with follow up on incident items needed from various departments to ensure incidents are completed/closed within the regulatory timeframe.
Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron Pharmaceuticals IncAssociate Director, CMC Regulatory Affairs (Hematology/Oncology)Tarrytown, NYRemote$157,200–$256,600 / yearPerform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; • Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. • Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Director, Regulatory Affairs Bausch & Lomb IncDirector, Regulatory Affairs$165,000–$220,000 / yearThe Director partners cross‑functionally with Clinical, Nonclinical, CMC, Quality, Safety, and Regulatory Operations to develop global regulatory strategies, lead health authority interactions, ensure high‑quality submissions, and manage regulatory risk across the product lifecycle. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe.
Associate Director, CMC Regulatory Affairs Recursion Pharmaceuticals IncAssociate Director, CMC Regulatory AffairsNew York, NYRemote$176,400–$228,250 / yearPowered by proprietary multimodal data, purpose-built AI models, and bilingual teams fluent in both science and AI, the Recursion OS is designed to translate complex science into medicines that matter - faster, better, and at scale - for patients who are waiting. Recursion is advancing a portfolio of differentiated investigational medicines across its wholly owned and partnered pipeline in oncology, rare disease, neuroscience, immunology, and other therapeutic areas with significant unmet need.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsNEW YORK, NY$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
Regulatory Affairs Senior Manager, Digitalization Becton Dickinson and CoRegulatory Affairs Senior Manager, DigitalizationFranklin Lakes, NJ$172,000–$275,200 / yearJob Summary: The Senior Manager of Regulatory Affairs, Digitalization is responsible for establishing, executing, and maintaining the central regulatory affairs strategy for digital tools and systems required for regulatory activities and work across BUs and Regions, specifically the Regulatory Information Management System (RIM and/or RIMSYS). Support Strategic Initiative Development: Identify, prioritize, and formalize global RA programs in partnership with the Senior Regulatory Leadership team, by analyzing internal performance data, external benchmarks, emerging digital, technical, and assessing impact, value and alignment with Global Regulatory Strategy.
Regulatory Affairs Strategist, Globalization Becton Dickinson and CoRegulatory Affairs Strategist, GlobalizationFranklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Globalization is responsible for alignment and execution of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across BU, Regional and Central teams. Knowledge and Skills: Organization & Planning: Organizes personal and organizational projects and tasks, setting measurable objectives and goals for management of assigned projects, enlisting resources to efficiently meet project needs.
Regulatory 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.
Regulatory Affairs Sr. Strategist, Globalization Becton Dickinson and CoRegulatory Affairs Sr. Strategist, 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. The Regulatory Affairs Strategist, Globalization, is responsible for alignment and execution of worldwide regulatory affairs strategies and practices related to their assigned area of focus and expertise across BU, Regional and Central teams.
Regulatory Affairs Specialist Becton Dickinson and CoRegulatory Affairs SpecialistFranklin Lakes, NJ$84,300–$138,900 / yearLife Balance Programs Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations. Other Life Balance Programs Adoption assistance, backup day care and eldercare, support for neurodivergent adults, children, and caregivers, caregiving assistance for elderly and special needs individuals, Employee Assistance Program (EAP), paid parental leave, support for fertility, birthing, postpartum, and age-related hormonal changes.
Associate 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.
Regulatory Affairs Strategist, Project Management Becton Dickinson and CoRegulatory Affairs Strategist, Project ManagementFranklin Lakes, NJ$137,500–$220,100 / yearThe Regulatory Affairs Strategist, Project Management, is responsible for acting as a subject matter expert and project manager for various high-profile initiatives and business critical projects within BD Regulatory Affairs that may influence across multiple functions. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
Legal & 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.
Associate Director, Regulatory Affairs, CMC BeOne Medicines AGAssociate Director, Regulatory Affairs, CMCNY$142,000–$192,000 / yearManage, prepare, and/or author CMC document packages for global regulatory submissions in support of development and lifecycle programs, including primary authorship and/or leadership of Module 3 (Quality) sections for INDs, CTAs, IMPDs, BLAs, MAAs, supplements, and variations. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity.
Manager/Senior Manager, Regulatory Affairs Operations Axsome Therapeutics IncManager/Senior Manager, Regulatory Affairs OperationsNew York, NYRemote$120,000–$150,000 / 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.
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.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion Syndax Pharmaceuticals IncDirector, Commercial Regulatory Affairs, Labeling, Advertising, and PromotionNew York, NYRemote$225,000–$250,000 / yearConducts precedent searches, analyzes relevant analogs or competitor labeling, labeling guidance and trends; and develops labeling language for inclusion to assigned product labels (TLP, CCDS, USPI, when applicable EU SmPC,) to ensure consistency with the overall product strategy, product claims and information in the CCDS. Leads Labeling cross-functional working group (LWG) and interacts with cross-functional senior leadership to resolve complex issues, including leading and contributing to cross-functional initiatives by providing expertise in labeling best practices.
NewAnalyst, Regulatory Affairs Oscar HealthAnalyst, Regulatory AffairsNew York, NY$31.45–$41.28 / hourYou will support the Regulatory Affairs Evidence of Coverage team by serving as a resource on Oscar processes and identify risks to escalate in partnership with their manager. Responsibilities: Support annual QHP filings by ensuring the quality and timeliness of annual filing inputs through initial submission and regulator facing negotiation periods.
Senior Associate, Regulatory Affairs, Promotional Operations BeOne Medicines AGSenior Associate, Regulatory Affairs, Promotional OperationsNY$93,600–$123,600 / yearActual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Essential Functions of the Job: Assists in acting as a centralized knowledge hub of Promotional Review Committee (PRC) and provides guidance to project owners/agencies/reviewers on the process to streamline material review.
Associate Director, Regulatory Affairs BeOne Medicines AGAssociate Director, Regulatory AffairsNY$146,700–$196,700 / yearProvides strategic and operational regulatory direction on assigned projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval, risk assessments, critical issue management and advice on health authority interactions. Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders.
Regulatory 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.
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.
Senior 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.
Medical Director, Clinical Regulatory Affairs Oscar Health IncMedical Director, Clinical Regulatory AffairsNew York, NYRemote$264,000–$346,000 / yearWork Location: You must reside in one of the following states: Arizona, California, Colorado, Connecticut, D.C., Florida, Georgia, Illinois, Iowa, Maryland, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York City, North Carolina, Ohio, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, or Utah. You will advise senior leadership and work closely with teams across the organization to ensure clinical operations align with policy and regulatory intent.
Regulatory Affairs Director - Hybrid CareSourceRegulatory Affairs Director - HybridBronx, NY$135,600–$237,400 / yearJob Summary: The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations, reporting, plan development and renewal, credentialing, Fraud, Waste & Abuse Special Investigations, provider network and relations, regulatory updates and compliance matters. 2 Days work from home; 3 Days work in Bronx office each week Compensation Range: $135,600.00 - $237,400.00 CareSource takes into consideration a combination of a candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level.