Regulatory Specialist A L Schutzman CompanyRegulatory SpecialistWaukesha, WisconsinAssist the Supervisor in responding to customer inquiries regarding food safety and quality related documentation; including but not limited to filling out surveys, providing existing documentation, creating technical documentation and providing information through online customer portals. Assist the Supervisor in the development of finished product specification and labeling information, as well as review of final labels; including development of nutrition facts panels, label statements, product claims and claim substantiation.
Director / Senior Director, Regulatory Affairs Advertising And Promotion Immunome IncDirector / Senior Director, Regulatory Affairs Advertising And PromotionBothell, WA$222,933–$310,500 / yearImmunome is seeking a highly experienced and strategic Director / Senior Director, Regulatory Affairs Advertising and Promotion to provide regulatory leadership for U.S. advertising, promotional labeling, and medical communications across our oncology portfolio. The successful candidate will bring deep expertise in FDA advertising and promotion regulations and OPDP practices, strong judgment and risk-based decision making, and proven leadership in medical-legal-regulatory review environments.
NewIBMi System Developer/ Programmer Specialist CAIIBMi System Developer/ Programmer SpecialistConcord, NH$55–$60In addition to ongoing support, this role will actively contribute to the organization’s strategic migration from IBM i to Hyland’s OnBase WorkView platform, ensuring smooth data transitions, integration planning, and operational continuity throughout the migration process. The role emphasizes ensuring system stability, diagnosing and resolving technical issues, and optimizing or enhancing existing programs to comply with regulatory changes and evolving business processes, rather than focusing on the development of entirely new solutions.
NewVeeva RIM Specialist ImmunityBioVeeva RIM SpecialistSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. 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.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyWaltham, MA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorHopewell, New JerseySUMMARY: Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
Senior Manager, Global CMC Regulatory Affairs Xeris PharmaceuticalsSenior Manager, Global CMC Regulatory AffairsChicago, IL$155,750–$213,600 / yearStarting pay is determined based on a variety of factors, including the role, job-related knowledge, skills, experience, education, internal equity, market data, and the location of the role, where applicable. Develop and create CMC regulatory strategy for integrated development plans and long-term planning at a cross-functional level for product(s), consistent with the corporate and project objectives.
NewRegulatory Affairs and Compliance Senior Advisor Edison InternationalRegulatory Affairs and Compliance Senior AdvisorRosemead, CA$161,700–$242,600 / yearIn this job, you'll act as the External Regulatory Audit Manager, responsible for managing the Company's response to multiple external regulatory audits simultaneously conducted by the CPUC, Office of Electric Infrastructure Safety (OEIS), FERC, 3rd Party Auditors, NERC and WECC that have financial, operational, and/or regulatory impact on the Company. Experience working in any of the following organizational units: Energy Procurement, Transmission and Distribution, Customer Service Programs, Regulatory Affairs, or Finance.
Product Safety and Regulatory Affairs Coordinator Global Channel ManagementProduct Safety and Regulatory Affairs CoordinatorConnecticutProduct Safety and Regulatory Affairs Coordinator duties: Ensure that customers and employees are fully informed about the health and safety characteristics of products and raw materials and that all products marketed by and are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.). Provide timely assessments of developmental materials, including chemical materials and formulations, in order to assure that their health and safety, transportation, and disposal considerations are fully understood relative to business impact and customer satisfaction.
New["Regulatory Change Management - AI","Regulatory Change Management - AI"] Mizuho Bank["Regulatory Change Management - AI","Regulatory Change Management - AI"]New York$180,000–$210,000 / yearThe Regulatory Affairs Group centrally manages MUSO's regulatoryengagement and supervisory priorities across US regulators, including examinations, information requests, continuous monitoring meetings, meeting preparation, training, supervisory commitments, the timely closure of remediation findings, horizon scanning for emerging regulations, regulatory change management and maintenance of the laws, rules and regulations library. The candidate will identify, develop and build out AI and Generative AI capabilities that enhance how MUSO scans for emerging regulations, manages regulatory change, maintains its laws, rules and regulations library, and engages with its regulators, while ensuring comprehensive AI governance and risk management requirements are met.
Analyst, Regulatory Affairs and Compliance The Scotts Miracle-Gro CoAnalyst, Regulatory Affairs and ComplianceMarysville, OH$111,500–$131,200 / yearBe part of something bigger by joining one of our Employee Resource Groups focusing on diversity and inclusion, family, education and sustainability: Scotts Women's Network, Scotts Black Employees' Network, Scotts Veterans Network, Scotts Young Professionals, Scotts Pride Network (GroPride), Scotts Associates for a Greener Earth (SAGE), Scotts Family TREE and our Associate Boards. As a regulatory leader, you will directly manage a team of 5-10 regulatory professionals, driving process improvements, overseeing complex registration projects, and serving as the primary liaison with regulatory agencies (EPA and state departments of agriculture).
Regulatory Affairs Manager - CMC & Labeling United Therapeutics CorporationRegulatory Affairs Manager - CMC & LabelingRaleigh, NCDirect and manage direct reports to include responsibilities for training, goal setting and achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need.
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.
Manager, Regulatory Affairs Iovance Biotherapeutics IncManager, Regulatory AffairsSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.
Executive Director, Regulatory Affairs Precigen IncExecutive Director, Regulatory AffairsGermantown, MDThis role is responsible for defining regulatory strategy, planning and the preparation of US and eventually global regulatory submissions to achieve timely approvals of biologic licensing and marketing authorization applications and post-approval lifecycle changes for Precigen CAR-T and AdenoVerse immunotherapy Products. We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience) reporting into the SVP Regulatory Affairs who is responsible for oversight of IND/IMPD, BLA and ex-US activities for the CAR-T and immunotherapy products.
Regulatory Affairs Project Manager The Walt Disney CompanyRegulatory Affairs Project ManagerCelebration, FL$120,800–$161,900 / yearCreate project plans to support long term growth for cross-functional teams, including Legal, Marketing, Business Operations, Compliance, Finance, Technology, Member services, Walt Disney World Operations, and corporate partners such as Tax, Controllership, and the Corporate Secretary. The role will require a strong acumen of the timeshare business, excellence in legal research and document creation, and expert level project management skills from ideation to sustainment.
Regulatory Affairs Associate - Full Time - Germantown, TN West Cancer CenterRegulatory Affairs Associate - Full Time - Germantown, TNGermantown, TNPosition Overview The Regulatory Affairs Associate I works closely with Sponsors, CROs, investigators, and research staff to coordinate regulatory submissions and approvals for multiple studies. Join Us If you are detail-oriented and passionate about supporting clinical research and regulatory compliance, we invite you to join West Cancer Center as a Regulatory Affairs Associate I and contribute to advancing innovative cancer care.
NewQuality Systems Specialist CONAGRAQuality Systems SpecialistNorth Mankato, MN$28Reporting to the Plant Quality Manager, you will support the Mankato manufacturing facility by developing, implementing, and maintaining food safety and quality systems to ensure compliance with regulatory, corporate, and Safe Quality Food requirements. Provide technical support, training, and guidance to team members while leading programs such as cross checks, environmental monitoring, sensory evaluation, and data systems support.
NewContracts Specialist Sparks GroupContracts SpecialistLeesburg, VASparks Group has partnered with a local government contractor to seek a highly skilled and results-oriented Contracts Specialist to join a collaborative team issuing important solicitations, proposals and highly visible contracts for the organization. The Contracts Analyst serves as a key role in managing the negotiation, analysis and administration of contracts supporting procurement efforts.
NewPharmacy Benefits Support Specialist CornerStone StaffingPharmacy Benefits Support SpecialistThe Colony, TXThe Pharmacy Benefits Support Specialist ensures patients and pharmacy partners receive accurate, timely support related to prescription benefits and claim inquiries. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from CornerStone and its affiliates, and contracted partners.
NewSafety & Compliance Manager Specialist The LEGO GroupSafety & Compliance Manager SpecialistRichmond, VA$104,327–$156,491 / yearActing as the key interface between WS&O, EHS, GWP, operations, and the IFM partner, this role ensures that safety and compliance requirements are understood, followed, documented, and escalated before they become operational risks. The Safety and Compliance Manager plays a crucial role in supporting the broader organization by providing clear compliance oversight, audit readiness, risk management, and safety governance across LVA facilities operations.
Senior Program Director (Commercial Regulatory Affairs, Fully Remote) Dawar ConsultingSenior Program Director (Commercial Regulatory Affairs, Fully Remote)South San Francisco, CaliforniaRemoteYou will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ".
NewCorporate Counsel II - Regulatory Affairs Aldi IncCorporate Counsel II - Regulatory AffairsAurora, ILResearches, monitors, assesses, and communicates emergent legal trends, new legal and regulatory issues and laws, legislation, regulations, agency guidance, rulemaking activity, enforcement developments, and court decisions in multiple jurisdictions to drive strategy and operational goals; identifies and communicates impactful updates and business implications to direct leader and relevant business units. This role is particularly well-suited for an attorney with experience advising on sustainability and environmental compliance initiatives, including packaging regulations, extended producer responsibility (EPR) programs, waste and recycling requirements, climate-related regulatory developments, and other emerging ESG obligations.
Senior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsLansing, MIRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Associate Manager, Regulatory Affairs Strategy - Oncology Regeneron Pharmaceuticals IncAssociate Manager, Regulatory Affairs Strategy - OncologyTarrytown, NY$109,900–$179,300 / yearDiscover your role: Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Associate 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.
Principle Regulatory Affairs Strategy Associate Aequor Technologies LLCPrinciple Regulatory Affairs Strategy AssociateLake Forest, CAThe Principle Regulatory Affairs Strategy Associate, reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. Expectations / Responsibilities: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Documentation Associate Specialist Kyyba IncDocumentation Associate SpecialistPine Point, ME$24–$27 / hourContractorThis position is responsible for reviewing and processing change requests for new documents and revisions to existing documents; responsible for processing, organizing and maintaining the Document Control System in accordance with applicable quality and regulatory guidelines. ensure that changes made to documents are appropriate, justified and approved by the required functional areas according to established procedures.
NewSpecialist Director, Cloud Security KPMGSpecialist Director, Cloud SecurityDallas, TX$169,005–$370,530 / yearResponsibilities: Provide strategic leadership for cloud security governance across AWS and Azure environments, including oversight of security posture, risk remediation, compliance, and continuous monitoring programs; Lead enterprise cloud asset, firewall, and security exception governance programs, including inventory accountability, lifecycle management, policy compliance, risk acceptance, and regulatory oversight. Set the strategic direction for secure adoption of cloud and AI-enabled technologies by establishing security baselines, guardrails, policies, and control frameworks; Partner with cloud, cybersecurity, architecture, and business leaders to embed security into platform strategy, architecture decisions, and enterprise cloud transformation initiatives.
NewGIS & Land Survey Specialist Walt Disney World ResortGIS & Land Survey SpecialistLake Buena Vista, FL$91,000–$121,900 / yearAs a GIS & Land Survey Specialist, you will bridge the worlds of land surveying and Geographic Information Systems (GIS), supporting the legal, planning, design, construction, and ongoing operations across the resort and district. Update GIS databases with project and sustaining activities, ensuring compatibility with utility models and collecting field data using ArcGIS and mobile GIS apps.
Regulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, California$114,000–$228,000 / yearAs a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
NewLicensed Pharmacy Benefits Specialist CornerStone StaffingLicensed Pharmacy Benefits SpecialistThe Colony, TX$22–$24 / hourAs a Pharmacy Benefits Support Specialist, you'll play an important role in helping patients and pharmacy partners navigate prescription benefit questions and claim-related concerns. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from CornerStone and its affiliates, and contracted partners.
Aviation Regulatory Affairs Manager Rainmaker Technology CorporationAviation Regulatory Affairs ManagerEl Segundo, CaliforniaTrack and analyze FAA rulemaking with material impact on Rainmaker, including Part 108 BVLOS, evolving airworthiness frameworks, and federal contracting prerequisites (American Security Drone Act, FAR 52.240-1, DoD Blue UAS Cleared List). In doing so, they are expected to continuously challenge and improve how Rainmaker designs operating concepts, builds safety cases, and positions itself with the FAA — building durable institutional credibility that compounds across waivers, certifications, and rulemaking cycles.
Sr Regulatory Affairs Engineer Harley-Davidson IncSr Regulatory Affairs EngineerWauwatosa, WI$83,500–$129,300 / yearThis role will also be a critical input into the product development process by helping define project requirements and supporting the smooth delivery of the product plan by determining certification test needs and working to enable undisrupted shipment, sale & registration of product. The Sr Regulatory Affairs Engineer is responsible for developing and executing processes and activities required to certify motorcycles, systems and components in all markets in which Harley-Davidson does business.
Sr Regulatory Affairs Engineer (Wauwatosa, WI, US) Harley-DavidsonSr Regulatory Affairs Engineer (Wauwatosa, WI, US)Wauwatosa, WI$83,500–$129,300 / yearThis role will also be a critical input into the product development process by helping define project requirements and supporting the smooth delivery of the product plan by determining certification test needs and working to enable undisrupted shipment, sale & registration of product. The Sr Regulatory Affairs Engineer is responsible for developing and executing processes and activities required to certify motorcycles, systems and components in all markets in which Harley-Davidson does business.
Financial Specialist CredenceFinancial SpecialistEl Segundo, CA$150,000–$210,000The Financial Specialist will work closely with government leaders, program managers, and cross‑functional teams to support the Planning, Programming, Budgeting, and Execution (PPBE) process, ensuring accurate, timely, and compliant financial products across classified and unclassified portfolios. Support PPBE activities such as Program Objective Memorandum (POM) development, Budget Estimate Submissions (BES), Program Budget Reviews (PBR), and President’s Budget (PB) exhibits and justifications.
NewGeneral Attorney (Regulatory Affairs) U.S. Department of Homeland SecurityGeneral Attorney (Regulatory Affairs)Washington, DC$85,447–$197,200 / yearIf you are a current or former political Schedule A, Schedule C, Non-career SES or Presidential Appointee employee: Submit a copy of your applicable SF-50, along with a statement that provides the following information about your most recent political appointment: Position title, type of appointment (Schedule A, Schedule C, Non-career SES, or Presidential Appointee), agency and beginning and ending dates of appointment. RAU attorneys serve as regulatory counsel and play a significant role in the development and promulgation of regulatory actions relating to a variety of law enforcement authorities and functions, including immigration arrest, detention, and processing as well as oversight of the Student and Exchange Visitor Program.
Executive Advisor, Enterprise Risk and Regulatory Affairs UMass Chan Medical SchoolExecutive Advisor, Enterprise Risk and Regulatory AffairsWestborough, MAThe incumbent will work closely with ForHealth Consulting Deputy Executive Vice Chancellor, Associate Executive Vice Chancellors (AEVCs) and Managing Directors (MDs) to anticipate and address potential legal risks related to new and existing ForHealth business initiatives and internal processes; serve as a creative problem solver for complex business, legal, and compliance challenges to facilitate the development of business strategy and subsequent growth in products and services; and lead negotiations on behalf of ForHealth Consulting where appropriate. In this leadership position, the candidate must demonstrate influencing skills and organizational savvy to effectively interact with multiple internal business unit leaders at ForHealth Consulting, key stakeholders throughout the broader UMass Chan Medical School and University of Massachusetts system, and many other external partners in public and private organizations.
Manager, Regulatory Affairs ScottsMiracle-GroManager, Regulatory AffairsMarysville, OhioBe part of something bigger by joining one of our Employee Resource Groups focusing on diversity and inclusion, family, education and sustainability : Scotts Women’s Network, Scotts Black Employees’ Network, Scotts Veterans Network, Scotts Young Professionals, Scotts Pride Network (GroPride), Scotts Associates for a Greener Earth (SAGE), Scotts Family TREE and our Associate Boards. As a regulatory leader, you will directly manage a team of 5–10 regulatory professionals, driving process improvements, overseeing complex registration projects, and serving as the primary liaison with regulatory agencies (EPA and state departments of agriculture).
Payroll Operations Analyst/Specialist Pinnacle Technical ResourcesPayroll Operations Analyst/SpecialistTempe, Arizona$40–$45 / hourContractorThe specific compensation for this position will be determined by several factors, including the scope, complexity, and location of the role, as well as the cost of labor in the market; the skills, education, training, credentials, and experience of the candidate; and other conditions of employment. Successfully placed or hired candidates would only be asked for banking details after accepting an offer from us during our official onboarding processes as part of payroll setup.
NewCertified Pharmacy Support Specialist CornerStone StaffingCertified Pharmacy Support SpecialistThe Colony, TX$22–$24 / hourSuccess in this role comes from delivering compassionate support, maintaining accurate documentation, and ensuring every member receives a positive, seamless experience. Working closely with patients, healthcare providers, pharmacies, and assistance programs, you'll help remove barriers to prescription access while providing exceptional service throughout the process.
Chief Deputy Legal Counsel North Carolina Real Estate CommissionChief Deputy Legal CounselRaleigh, NCFull timeRepresents Commission in civil litigation proceedings at State level; prepares documents such as discovery, interrogatories, and depositions; drafts pleadings; prepares witnesses; prepares and presents arguments before judge; prepares and argues various appropriate legal motions; and may participate in jury selection in limited cases and defend cases before a jury under the supervision of the Director and/or Assistant Director of Regulatory Affairs. Prepares and responds to assigned disciplinary and litigation cases; conducts necessary research on real estate and interrelated laws relating to Commission cases and court rulings; determines merits of a case and points of law; analyzes pertinent statutory, common and case law, administrative and procedural rules; develops case strategy and legal arguments.
NewBilingual Loan Sales Specialist OneMain FinancialBilingual Loan Sales SpecialistLake Wales, FLKey Word Tags Sales, Collections, Retail, Loan Sales, Customer Service, Customer Care, Business Development, New Grad, Newly Graduated, Entry level, Financial Sales, Management Development, Management Trainee, Finance, Full-time, Career, Benefits, Customer experience, Financial Representative, Credit, Leadership, Manager Trainee #OMHTF In our more than 1,300 community branches and across the U.S., team members help millions of customers solve critical financial needs, including debt consolidation, home and auto repairs, medical procedures and extending household budgets.
Federal Contracts & Compliance Specialist (working on request) Ariel PartnersFederal Contracts & Compliance Specialist (working on request)RemotePer diemYou’ll collaborate with various stakeholders to negotiate terms, manage vendor relationships, and maintain meticulous documentation. This is an exciting opportunity to contribute to strategic planning and business development while ensuring that our organization meets its contractual obligations.
Senior Specialist, Global Regulatory Systems The Cooper Companies IncSenior Specialist, Global Regulatory SystemsVictor, NY$91,928–$122,570 / yearEssential Functions & Accountabilities: Supporting RIM or other systems: Support implementation and improvement of regulatory systems and processes, including: Veeva Vault RIM (communication, adoption, roadmap support, best practices). Liaises with other, non-RA internal functions to assist with ensuring that all documentation required to support global product registration activities is adequately embedded in the QMS and is available in the RIM system for end users.
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.
Business Development Representative, Quality & Regulatory Affairs Technology IQVIABusiness Development Representative, Quality & Regulatory Affairs TechnologyTampa, FloridaAs a Business Development Representative, you will play a key role in driving growth for the Quality & Regulatory Affairs (QARA) Center of Excellence by championing SmartSolve , a leading electronic QARA Management System, as part of our strategic Go-To-Market (GTM) initiatives . The ideal candidate brings a passion for consultative selling , experience with enterprise software solutions , and the drive to build relationships, open doors, and make a measurable impact in one of the most dynamic sectors of healthcare technology .
Principal Consultant, Biologist/Regulatory Specialist, Power and Renewables ERMPrincipal Consultant, Biologist/Regulatory Specialist, Power and RenewablesWalnut Creek, California$111,000–$160,905 / yearAs the largest global pure play sustainability consultancy, we partner with the world’s leading organizations, creating innovative solutions to sustainability challenges and unlocking commercial opportunities that meet the needs of today while preserving opportunity for future generations. Our diverse team of world-class experts supports clients across the breadth of their organizations to operationalize sustainability, underpinned by our deep technical expertise in addressing their environmental, health, safety, risk and social issues.
Senior Regulatory Affairs Program Manager ImmunityBioSenior Regulatory Affairs Program ManagerSummit, NJLead the design, planning, and execution of complex, cross-functional regulatory programs and strategic initiatives, establishing integrated project plans, timelines, milestones, deliverables, resource allocation, and proactive risk-mitigation strategies to ensure successful outcomes. ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
Regulatory Affairs ManagerTitusville NJ/ Raritan NJ/ Springhouse PA Integrated Resources, IncRegulatory Affairs ManagerTitusville NJ/ Raritan NJ/ Springhouse PAHopewell Township, New JerseyContractorProvides cross-functional leadership to the submission teams in executing the finalized pre-submission plan, including direct management of Modules 1 and 2.Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA – EMEA - APJLA): Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions. ) Monitors regulatory driven key milestones, decision points and critical path activitiesCreates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short and long term deliverables; informs stakeholders on project deliverables status.
Sr. Regulatory Affairs Analyst - Medical Devices Tunnell Government ServicesSr. Regulatory Affairs Analyst - Medical DevicesWashington, DCMinimum 15 years of device development; Government or industry experience in regulatory and/or quality affairs for diagnostic devices, particularly seeking expertise with imaging devices, software as a medical device, in vitro diagnostic devices, wearable technologies, digital health, and home use diagnostics. Duties of the position: This position will serve as regulatory affairs subject matter expert for multiple BARDA programs and projects involving development and manufacturing of in vitro diagnostic and device medical countermeasures specific to influenza, emerging infectious disease, CBRN threats (e.g.