Regulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerAnywhere, NYThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Manager, Regulatory Affairs, Advertising & Promotion Regeneron Pharmaceuticals IncManager, Regulatory Affairs, Advertising & PromotionNY$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 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.
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 Analyst, Regulatory Affairs Oscar Health IncSenior Analyst, Regulatory AffairsNYRemote$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.
NewAssociate 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, 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 Associate, US Regulatory Affairs BeOne Medicines AGSenior Associate, US Regulatory AffairsNY$93,600–$123,600 / yearThe Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive. Essential Functions of the job: With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
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.
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.
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.
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.
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.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion Syndax Pharmaceuticals IncDirector, Commercial Regulatory Affairs, Labeling, Advertising, and PromotionNYRemote$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.
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 / yearFull timeOversee 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.
Legal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VP Bank of ChinaLegal & Compliance Department-Regulatory Affairs Office (RAO) AVP/VPNew York, New York$110,000–$230,000 / yearFull timeOversee 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, CMC Regulatory Affairs (Hematology/Oncology) Regeneron Pharmaceuticals IncAssociate Director, CMC Regulatory Affairs (Hematology/Oncology)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.
Manager/Senior Manager, Global Regulatory Affairs Menarini GroupManager/Senior Manager, Global Regulatory AffairsNew York$135,000–$180,000 / yearThanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.
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.
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.
Analyst, 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.
Analyst, Regulatory Affairs Oscar Health IncAnalyst, Regulatory AffairsNY$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.
Director, Regulatory Affairs Nektar TherapeuticsDirector, Regulatory AffairsNY$240,000–$275,000 / yearThis role oversees end-to-end planning and delivery of global clinical submissions, leads the creation and release of core regulatory dossiers, drives country-level customization strategies, and ensures high-quality responses to regulatory RFIs to support timely trial startup and advancement. Nektar currently anticipates the base salary for the Senior Specialist, Clinical Regulatory Affairs to range from $240,000 to $275,000 for candidates in the Bay Area and will depend, in part, on successful candidate''s location and qualifications for the role, including education and experience.
Director, Regulatory & Administrative Affairs - Institute for Transformative Clinical Trials Mount Sinai Health SystemDirector, Regulatory & Administrative Affairs - Institute for Transformative Clinical TrialsNew York, NY$95,450–$143,175 / yearThe Director of Regulatory & Administrative Affairs for the Mount Sinai Institute for Transformative Clinical Trials provides strategic leadership and operational oversight for regulatory, safety, and administrative activities supporting a portfolio of sponsor-led, investigator-initiated, federally funded, and industry-sponsored clinical research studies. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time - discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.
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.
NewSenior Attorney/Assistant Attorney 1/2/3 - Albany, Buffalo, NYC - Legislative and Regulatory Affairs (NY HELPS) New York State Thruway AuthoritySenior Attorney/Assistant Attorney 1/2/3 - Albany, Buffalo, NYC - Legislative and Regulatory Affairs (NY HELPS)Buffalo, NY$66,951–$121,413 / yearIf you are a person with a disability and wish to request that a reasonable accommodation be provided for you to participate in a job interview, please contact: Department of Labor, Attn: Director, Office of Diversity, Equity, Inclusion and Accessibility (ODEIA), Building 12, Albany, NY 12226 (Phone (518) 457-1984 and/or fax (518) 485-2575). If you are interested in the NY-HELPS program, or this position, you may reply to this vacancy posting, or you may visit the New York State Department of Civil Service website at https://www.cs.ny.gov/help/ (copy and paste in browser) to register today, in three easy steps.
Vice President, Food Safety, Quality & Regulatory Affairs DO & CO AGVice President, Food Safety, Quality & Regulatory AffairsJamaica, NY$200,000–$230,000 / yearThe ideal candidate is a transformational leader with extensive experience in multi-site food manufacturing, airline catering, commissary, or high-volume food production environments and a proven ability to build world-class food safety programs that protect consumers, strengthen customer partnerships, and uphold the integrity of the DO & CO brand. DO & CO is seeking an accomplished Vice President of Food Safety, Quality & Regulatory Affairs to provide executive leadership for all food safety, quality assurance, regulatory compliance, sanitation, supplier quality, and product integrity initiatives across our North American operations.
NewSenior 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.
Regulatory Affairs Director - Hybrid (Bronx Office) CareSourceRegulatory Affairs Director - Hybrid (Bronx Office)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. 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.
Quality Assurance and Regulatory Affairs Specialist EMED TechnologiesQuality Assurance and Regulatory Affairs SpecialistNew YorkLead/assist with Corrective and Preventative Action (CAPA) investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records. Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
Regulatory Affairs Lead Eastman Kodak CoRegulatory Affairs LeadRochester, NY$125,000–$130,000 / yearThis role provides hands-on regulatory leadership for FDA submissions, clinical studies, and product lifecycle management, while helping build scalable regulatory processes aligned with FDA medical device, drug, and combination product requirements. Combination Product & Early Pharmaceutical Readiness Support regulatory planning for combination products and future pharmaceutical development in alignment with FDA drug, device, and combination product regulations.
Director / Senior Director of Regulatory Affairs PathosDirector / Senior Director of Regulatory AffairsNew YorkDirect IND lifecycle management experience: you have owned INDs from filing through amendment cycles, authored DSURs, prepared IB updates, and built FDA meeting packages as the primary author. That means authoring DSURs, preparing IB updates and IND amendments, building FDA meeting packages, managing ClinicalTrials.gov listings, and overseeing eCTD publishing.
Director - Compliance Coordination and Regulatory Affairs Credit Agricole SADirector - Compliance Coordination and Regulatory AffairsNY$190,000–$240,000 / yearThe Director- Compliance Coordination and Regulatory Affairs is a senior role within the Compliance Team responsible for the following functions:Regulatory Engagement & Examination ManagementServe as Compliance primary point of contact for U.S. regulatory agencies during examinations, inquiries, and ongoing supervisory activities;Coordinate and manage end-to-end regulatory examinations, including preparation, document production, regulatory meetings, and remediation efforts;Develop and maintain examination response protocols and methodology;Track and manage regulatory requests to ensure timely, accurate, and complete responses;Review and challenge regulatory deliverables;Support regulatory inquiries and examinations in the Americas and across business lines as needed;Internal Audit CoordinationPartner with Internal Audit to coordinate compliance-related audit reviews;Manage audit response processes, including deliverables validation and review;Strategic Project LeadershipLead and contribute to high-priority compliance projects and department-wide initiatives;Collaborate with cross-functional teams to implement compliance program enhancements;Drive process improvements and automation opportunities within the compliance function;Stakeholder ManagementBuild and maintain productive relationships with regulatory agencies;Partner with other divisions (business lines/support functions) on compliance matters;Provide regular updates to senior leadership on regulatory developments and examination status. This team has a number of different functions, but its primary functions are the management of interactions with US Regulators, management of compliance projects, tracking and reporting of issues, quality assurance, regulatory watch and support to regulatory changes, compliance communication, and regulatory coordination.
Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - Immunology & InflammationTARRYTOWN, NY$128,600–$210,000 / yearA typical day might include the following: 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.
Director, Regulatory Affairs Recursion Pharmaceuticals IncDirector, Regulatory AffairsNew York, NYRemote$228,250–$280,720 / 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.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNY$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Senior Managing Counsel, Regulatory Affairs Mastercard IncSenior Managing Counsel, Regulatory AffairsNew York City, NY$250,000–$400,000 / yearAll activities involving access to Mastercard assets, information, and networks comes with an inherent risk to the organization and, therefore, it is expected that every person working for, or on behalf of, Mastercard is responsible for information security and must: Abide by Mastercard's security policies and practices; Ensure the confidentiality and integrity of the information being accessed; Report any suspected information security violation or breach, and. The Global Regulatory team is looking for a Senior Managing Counsel, Regulatory to lead the MTS Regulatory team and drive the regulatory compliance program for MTS's global portfolio of money transmission/payment services licenses.
Regulatory Affairs Specialist ElliquenceRegulatory Affairs SpecialistBALDWIN, NYFull timeThis role collaborates cross-functionally with Quality, Engineering, Clinical, and Manufacturing teams to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities. Create documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance.
Regulatory Government Affairs Specialist (Hybrid) NYCM InsuranceRegulatory Government Affairs Specialist (Hybrid)Edmeston, New YorkActing as a liaison for NYCM Insurance by working and collaborating with other industry trade associations (i.e., Barrett Associates, National Association of Mutual Insurance Companies (NAMIC) and New York State Department of Financial Services (NYSDFS)). Provide strategic insight, direction, education, and clear communication to divisional partners to ensure comprehension of all regulatory and legislative introductions or amendments.
NewManager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - OncologyNY$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.
Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron Pharmaceuticals IncDirector, Regulatory Affairs Strategy - Genetics MedicineNY$205,000–$341,600 / yearThe Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.
Director, CMC Regulatory Affairs Recursion Pharmaceuticals IncDirector, CMC Regulatory AffairsNew York, NYRemote$228,250–$280,720 / 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 Director Regulatory Affairs, CMC BeOne Medicines AGSenior Director Regulatory Affairs, CMCNY$204,500–$274,500 / yearProvide strategic and operational leadership for the development and execution of global biologics Regulatory CMC strategies for the responsible regions, including oversight of authoring, review, and lifecycle management of CMC sections of CTDs (Modules 2 and 3) for INDs, BLAs, MAAs, and post approval submissions. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based counterpart and global cross-functional stakeholders in the development and execution of global CMC regulatory strategies across the product lifecycle.
Principal SME Regulatory Affairs — Banking & AI Compliance MonstroPrincipal SME Regulatory Affairs — Banking & AI ComplianceNew York, NY$250,000–$320,000 / yearDevelop clear, well-reasoned positions on nuanced questions: where AI-driven financial guidance sits relative to regulated advice, how data flows within banking ecosystems, and how Monstro is appropriately classified as a vendor. We are looking for someone who has spent years inside or alongside financial institutions, understands how regulators think, and has built the kind of credibility that makes banks and compliance officers trust you.
Regulatory Affairs Manager EMED TechnologiesRegulatory Affairs ManagerNew YorkRegulatory Affairs Manager lead all aspects of Regulatory Affairs related to medical devices regulatory submissions and submissions for global markets, supports all aspects of the Quality Management System, design and development, and distribution. Research and execute clinical validation activities relative to usability and post-market surveillance as well as improvement of existing and new devices.
Regulatory Affairs Specialist Actalent IncRegulatory Affairs SpecialistBaldwin, NY$75,000–$90,000 / yearWe are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. 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.
Director, Global Regulatory Affairs Protara Therapeutics IncDirector, Global Regulatory AffairsNY$228,000–$233,000 / yearThe Director, Global Regulatory Affairs will provide leadership on ex-US regulatory activities for Protara's product portfolio, and responsibility will focus on clinical study applications and provide regulatory leadership on the project teams in this area. The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG), as well as a Phase 2 trial in pediatric patients with LMs.
Medical Affairs Hematology Oncology Clinical Nurse Educator, Medical Affairs East Coast Karyopharm Therapeutics IncMedical Affairs Hematology Oncology Clinical Nurse Educator, Medical Affairs East CoastNY$175,000–$195,000 / yearOur lead therapy, XPOVIO (selinexor), is a first-in-class inhibitor of exportin 1 (XPO1) and is approved in the U.S. for adults with relapsed or refractory multiple myeloma, with approvals in more than 50 countries and territories outside the U.S. We are also exploring opportunities to evaluate XPO1 inhibition across myeloproliferative neoplasms and TP53 wild-type driven solid tumors using next-generation compounds, including eltanexor. Role Overview & Key Functions: The Medical Affairs Hematology Oncology Clinical Nurse Educator, Medical Affairs is responsible for the identification and engagement of a targeted group of healthcare professionals (HCPs), including physicians, nurses, nurse practitioners, physician assistants, pharmacists, and other members of multidisciplinary oncology care teams.
Vice President, Medical Affairs Lexeo Therapeutics IncVice President, Medical AffairsNY$300,000–$350,000 / yearLexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Reporting to the Chief Medical Officer, this role will set the strategic direction for Medical Affairs, overseeing scientific communications, congress strategy, external expert engagement, medical information, medical evidence generation and medical education.