Director, US Regulatory Affairs AltimmuneDirector, US Regulatory AffairsMorristown, NJFull timePrior experience reviewing and submitting advertising and promotional materials for drugs and biological products is preferredExcellent planning, organization, and project management skills, including the ability to adjust to rapidly changing priorities and manage multiple projects simultaneouslyMust be self-motivated with a positive attitude and the ability to work well with othersExcellent oral and written communication skills. D., MD, PharmD with at least 6 years of regulatory experienceOperational experience in regulatory submissions management, compiling and managing eCTD submissions, and formal correspondence and liaison with regulatory agenciesThorough knowledge of FDA regulations and global regulatory guidelines governing clinical development, clinical trial applications, marketing, and post-approval application submissions.
Director, Institutional Research & Data Quality Brookdale Community CollegeDirector, Institutional Research & Data QualityNJReporting to the Associate Vice President, Planning & Institutional Effectiveness, the Director leads efforts to ensure the integrity, accessibility, and effective use of institutional data in support of strategic planning, accreditation, and data-informed decision-making. Master's degree in discipline such as behavioral sciences, statistics, higher education, information systems, data analytics, or a related field or a Bachelor's degree with an equivalent combination of relevant education and progressively responsible professional experience.
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 Director Medical Affairs (COVID 19/Viral Diseases) Shionogi & Co LtdSenior Director Medical Affairs (COVID 19/Viral Diseases)Florham Park, NJ$280,000–$350,000 / yearPartner with the Clinical Research team in the planning and review of Clinical Research programs, protocols and final study reports for clinical development projects, as well as in Clinical Research programs needed for the support of existing products and claims. This Senior Director Medical Affairs will have primary responsibility for the COVID-19/Viral Diseases COVID-19/Viral Diseases disease portfolio, with the flexibility to expand into other product areas as needed and as Shionogi Inc. continues to grow.
Vice President Regulatory Affairs - Cluster Perrigo Company CorporateVice President Regulatory Affairs - ClusterMorristown, NJAs VP, you will define the operating model, decision rights, governance and escalation pathways needed to connect Category Regulatory Affairs, Cluster Regulatory Affairs, Lifecycle Management, Regulatory Operations, Quality, Safety, Supply, R&D and Commercial teams into one execution-focused regulatory voice. In this role you will lead the Global Cluster Regulatory organisation and provide senior leadership for in-market regulatory strategy, execution, registration delivery, launch readiness, lifecycle transition and ongoing market support.
Executive Medical Director Immunology Clinical Development - RespiratoryPulmonary AbbVie IncExecutive Medical Director Immunology Clinical Development - RespiratoryPulmonaryFlorham Park, NJActs as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues.
Sr. Staff Regulatory Affairs Specialist VB Spine LLCSr. Staff Regulatory Affairs SpecialistAllendale, NJ$135,000–$145,000 / yearAs a Principal Regulatory Affairs Specialist in our Regulatory Affairs function within the Spine division, you'll apply broad and advanced knowledge of regulatory frameworks, requirements, and processes to advise cross-functional teams and leadership on complex projects and strategies - supporting global product development, lifecycle management, and regulatory. At VB Spine, join a high-performing Regulatory Affairs team where you'll provide senior-level strategic guidance that enables the successful global launch and continued compliance of innovative spinal technologies.
Biostatistics Director, Medical Affairs BridgeBio Pharma IncBiostatistics Director, Medical AffairsNY$222,300–$255,000 / yearThis includes, but is not limited to, providing scientific and methodological expertise to support medical strategy, publications, and external engagements; serving as the primary point of contact between biostatistics and the Medical Affairs team; collaborating with the team in development of publication strategy plans; maintaining and executing Supplemental Statistical Analysis Plans (SAPs); and assisting as needed with real-world evidence-generating requests. They interact with both internal and external cross-functional study teams to support the scientific communication effort, and partner with unblinded biometrics study team members to deliver needed statistical output in a timely fashion.
Senior Strategy Manager, Government Affairs | Housing Elise A.I. Technologies Corp.Senior Strategy Manager, Government Affairs | HousingNew York City, NY$200,000–$250,000 / yearStrong command of the legislative and regulatory landscape at the intersection of housing and technology (familiarity with fair housing, AI and data-privacy regulation, or affordable housing programs such as LIHTC and Section 8/PBRA is a strong plus). Monitor, analyze, and synthesize legislative and regulatory developments affecting EliseAI-across AI regulation, fair housing, data privacy, tenant screening, and affordable housing programs-and translate them into clear internal guidance.
Head of Asset in GU Oncology Clinical Development AbbVie IncHead of Asset in GU Oncology Clinical DevelopmentFlorham Park, NJPersonally or through a direct report, leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie's customers, markets, business operations, and emerging issues. Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
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.
Director, Regulatory Affairs American International GroupDirector, Regulatory AffairsJersey City, NJThe base salary range for this position in New York, NY is $175,000-190,000, and in New Jersey the range is $170,000-`185,000 the role is eligible for a bonus in accordance with the terms of the applicable incentive plan. o Identify and escalate key themes, potential risks and mitigation plans/strategy to proactively address key perceived risks before they become issues.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaNJ$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.
Manager, Project Management, Regulatory Legend Biotech CorpManager, Project Management, RegulatorySomerset, NJ$110,706–$145,303 / yearWorking closely with cross-functional teams, this individual will coordinate project activities, monitor timelines, facilitate effective communication, and provide administrative support to ensure projects are executed efficiently and meet key development milestones. Coordinate day-to-day project activities across cross-functional teams, including Research, CMC, Quality, Regulatory Affairs, Clinical Operations, and external partners.
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.
Head of Medical Affairs Lyell Immunopharma IncHead of Medical AffairsNY$370,000–$410,000 / yearThis leader is accountable for building and scaling a high-performing Medical Affairs organization and for providing enterprise-level oversight across a growing, multi-program portfolio-directly overseeing leads for lymphoma, solid tumors, and field medical-while driving scientific communication and education, professional and KOL relationships, patient advocacy, and digital innovation. The Head of Medical Affairs will partner closely with the Executive Committee, Clinical Development, Regulatory, Commercial, Market Access, and Manufacturing leadership to ensure a seamless experience for patients and for cell therapy treatment sites as they engage with Lyell to receive and administer our therapies.
Director, Medical Affairs Operations Lyell Immunopharma IncDirector, Medical Affairs OperationsNY$230,000–$280,000 / yearAs the team scales toward potential launch, this role builds and runs the systems, processes, and execution engine that allow Medical Affairs to operate with speed, consistency, and compliance - spanning scientific congresses and advisory boards, the Materials Review Committee (MRC), field medical support, budget and vendor management, and performance metrics. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response.
NewSenior Medical Director Oncology Clinical Development Solid Tumors AbbVie IncSenior Medical Director Oncology Clinical Development Solid TumorsFlorham Park, NJActs as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Associate Director, Strategic Planning and Operations, Office of the CMO, Solid Tumors BeOne Medicines AGAssociate Director, Strategic Planning and Operations, Office of the CMO, Solid TumorsNY$143,300–$193,300 / yearLiaison/partner between functional areas, including portfolio program management, translational research/biomarkers, medical writing, clinical operations, regulatory, medical affairs, biostats, global patient safety, data management, finance, new product planning, commercial, and other relevant functions for process improvements. General Description: Associate Director, Strategic Planning and Operations, Office of the CMO, Solid Tumors will report to Senior Director, Strategic Planning and Operations, to support the business operations of the CMO office, including budget planning, resource planning, goal setting and development prioritization.
Corporate Communications Director Apollo Global Management IncCorporate Communications DirectorNew York City, NY$170,000–$250,000 / yearDeep experience in investment and private capital, with hands-on experience in financial communications across credit and equities, M&A communications, issues and crisis management, and a sophisticated understanding of the regulatory and public affairs landscape. A leading contributor to addressing some of the biggest issues facing the world today - such as energy transition, accelerating the adoption of new technologies, and social impact - where innovative approaches to investing can make a positive difference.