JobotNewQuality Systems & Regulatory Manager JobotQuality Systems & Regulatory ManagerLos Angeles, CA$90,000–$120,000 / 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. They’re looking for a tech-savvy and detail-oriented Quality Systems & Regulatory Manager to lead food safety systems, labeling accuracy, customer compliance documentation, and cross-functional audit readiness.
Macpower Digital Assets Edge Private LimitedBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance Macpower Digital Assets Edge Private LimitedBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA ComplianceLos Angeles, CA$90,000–$140,000 / yearGuided by the core values of Beautiful, Healthy, and Refreshing, they innovate beyond traditional cosmetics and household products, delivering creative solutions tailored to evolving consumer needs. As the Senior Regulatory Affairs Manager, you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, and medical device products in North America—from concept to market launch.
CorDxRegulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxRegulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)San Diego, CA$80,000–$120,000With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. This position collaborates with cross-functional teams to provide regulatory input during product development and throughout the product lifecycle, helping to secure timely product approvals and regulatory clearances.
CorDxAssociate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxAssociate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)San Diego, CA$80,000–$120,000With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
CorDxSenior Regulatory Affairs Manager (Onsite) CorDxSenior Regulatory Affairs Manager (Onsite)San Diego, CAWith over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.
Huisong PharmaceuticalsRegulatory Affairs Manager Huisong PharmaceuticalsRegulatory Affairs ManagerSanta Ana, California$38–$45About Huisong:Founded in 1998, Huisong Pharmaceuticals specializes in the R&D and manufacturing of premium-quality natural ingredients for world-leading companies in the pharmaceutical, nutraceutical, food & beverage, and personal care industries. Today, Huisong Pharmaceuticals is a global operation with an extensive and dynamic product portfolio of natural products and ingredients, remaining firm in its values of "Nature, Health, Science", and continues to advance the world of medicine and nutrition for the well-being of humanity.
Medtronic PlcNewRegulatory Affairs Manager - Cardiovascular Surgery Medtronic PlcRegulatory Affairs Manager - Cardiovascular SurgerySanta Ana, CAIf you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Katalyst Healthcares & Life SciencesNewRegulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerSan Diego, CAMust be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical, Research and Development, Manufacturing, Quality, Marketing, Operations and corporate partner counterparts on complex projects. Demonstrated hands-on experience in preparing regulatory clearance/approvals for IVD products in the EU, USA, OUS; (Preferred experience: working experience with IVD submissions under IVDR Regulations is highly desirable).
VituityNewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CACommit to creating and demonstrating inclusivity within Vituity including codesigning, building, and executing strategies, policies, and practices that cultivate equity, inclusion, and fair opportunity for all; demonstrating preparedness to educate, mitigate, coach, and address daily bias and exclusion in partnership with the site leadership. Accountable for ensuring meaningful integration occurs: Identify opportunities for practice line integration to ensure the quality and efficiency of patient care delivery across the acute care continuum; assist with new service line startups; engage regularly with integrated site RDs.
Karwell TechnologiesRegulatory Affairs Manager Karwell TechnologiesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
CEDENTRegulatory Affairs Manager CEDENTRegulatory Affairs ManagerSanta Clarita, CAThe Regulatory & Quality Affairs Manager ensures all facilities and or business entities maintain full compliance with all applicable state & federal regulatory requirements and guidelines for the marketing, sales, warehousing and distribution of the company’s products in their respective target markets. Ensure that known compliance risks (via internal/external audits, changes in regulations, changes in business structure/products) are mitigated via quality/compliance plans.
University of California, IrvineRegulatory Affairs & Quality Assurance Manager University of California, IrvineRegulatory Affairs & Quality Assurance ManagerOrange, CaliforniaResponsibilities: Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance is responsible for all clinical research regulatory and quality assurance operational matters in fulfilling the mission of CCR under the University of California, Irvine - School of Medicine and the overall UC Irvine Health enterprise. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
iRhythm Holdings IncManager, Regulatory Affairs iRhythm Holdings IncManager, Regulatory AffairsSan Francisco, CARemote$127,000–$165,000 / yearLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Noodle & Boo, Inc.Manager, Product Integrity, Regulatory & Scientific Affairs Noodle & Boo, Inc.Manager, Product Integrity, Regulatory & Scientific AffairsCerritos, CANoodle & Boo is seeking a highly organized, scientifically rigorous, and detail-oriented Manager, Product Integrity, Regulatory & Scientific Affairs to support the day-to-day execution of formula governance, regulatory documentation, product compliance, technical recordkeeping, claims substantiation, COA review, and manufacturing quality consistency across our premium baby, maternity, and family care portfolio. Reporting to the Founder and ultimately the VP Product / Chief Product Officer, this role is cross-functional and operationally important, but remains a manager-level, hands-on role focused on execution, documentation control, quality follow-up, and compliance support.
Edwards LifesciencesSenior Manager, Regulatory Affairs TMTT Edwards LifesciencesSenior Manager, Regulatory Affairs TMTTIrvine, CA$145,000–$205,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
Iovance Biotherapeutics IncNewManager, Regulatory Affairs CMC Iovance Biotherapeutics IncManager, Regulatory Affairs CMCSan 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.
Pacira Pharmaceuticals, Inc.Senior Manager, Regulatory Affairs & Compliance Pacira Pharmaceuticals, Inc.Senior Manager, Regulatory Affairs & ComplianceSan Diego, California$120,000–$165,000 / yearThe range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications. Manage and maintain regulatory documentation, product registrations, and regulatory correspondence while serving as the primary liaison with regulatory authorities including FDA, notified bodies, and other agencies to drive product approvals, clearances, and registrations.
Bidgely Inc.Manager, Regulatory Affairs & Market Development Bidgely Inc.Manager, Regulatory Affairs & Market DevelopmentLos Altos, CARemote$140,000You will operate as a core member of Bidgely’s Regulatory Affairs function, working closely with internal partners across Sales, Go-to-Market, Product, and Engineering to ensure regulatory strategy actively supports customer adoption and market expansion. You will: Monitor and analyze state-level regulatory proceedings, legislation, and utility plans related to grid modernization, data analytics, demand-side management, energy efficiency, and customer experience.
Mitchell MartinProject Manager, Regulatory Affairs (Clinical and CMC) Mitchell MartinProject Manager, Regulatory Affairs (Clinical and CMC)Encinitas, CARemote$58.80–$84 / hourBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC.
Pattern Energy Group IncNewManager, Regulatory and Market Affairs Pattern Energy Group IncManager, Regulatory and Market AffairsSan Francisco, CA$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern's existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern's engagement in regulatory and market design changes, develop Pattern's positions and execute on strategies to achieve desired objectives.
Pattern Energy Group LPNewManager, Regulatory and Market Affairs Pattern Energy Group LPManager, Regulatory and Market AffairsSan Francisco, California$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern’s existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern’s engagement in regulatory and market design changes, develop Pattern’s positions and execute on strategies to achieve desired objectives.
Apogee Therapeutics IncSenior Manager, Regulatory Affairs Project Management Apogee Therapeutics IncSenior Manager, Regulatory Affairs Project ManagementSan Diego, CA$150,000–$170,000 / yearReporting to the Director of Program management, you will also work closely with other project and program managers within the Program Management Office (PMO) implementing robust PM processes and building effective tools and systems. This role blends regulatory expertise with advanced project management skills, developing complex plans to enable successful Regulatory submission activities and ensuring cross-functional integration across regions.
University of California, IrvineRegulatory Affairs Coordinator University of California, IrvineRegulatory Affairs CoordinatorOrange, CaliforniaProven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
PerkinElmerNewManager, Quality Assurance & Regulatory Affairs PerkinElmerManager, Quality Assurance & Regulatory AffairsPasadena, CAProject Farma (PF) team members collaborate with cross-functional teams to build trusted client relationships, deliver an exceptional customer experience, and contribute to business growth by identifying opportunities and. The successful candidate will work remotely and be willing to travel domestically to meet client project requests, including short-term full time work on client sites.
Metagenics LLCNewSr. Specialist, Regulatory Affairs Metagenics LLCSr. Specialist, Regulatory AffairsAliso Viejo, CAIndustry Surveillance: Monitors competitive claims, FDA's and FTC''s actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Google LLCNewStrategy and Operations Lead, Regulatory Affairs Google LLCStrategy and Operations Lead, Regulatory AffairsMountain View, CAYou will also partner with teams across Google and Alphabet's Public Policy, Compliance, Legal, Engineering, Finance and product areas to support the handling of some of the most important issues for the company today. In this role, you will work closely with members of Regulatory Affairs and act as the central operations support for the department"s role in the broader regulatory lifecycle.
MetagenicsNewSr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsAliso Viejo, CaliforniaMonitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Procept Biorobotics CorpSenior Regulatory Affairs Specialist Procept Biorobotics CorpSenior Regulatory Affairs SpecialistSan Jose, CA$145,000–$170,000 / yearRepresent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments, interpreting the impact that projects such as design changes will have on labeling content, and implementing necessary modifications to the product labeling. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow as both managers and learners in an environment that challenges, supports, and broadens.
Public Health Foundation Enterprises, InRegulatory Affairs Coordinator Public Health Foundation Enterprises, InRegulatory Affairs CoordinatorRichmond, CAFull timeKnowledge of current Good ClinicalPractices (cGCP), current Good Manufacturing Practices (cGMP), Good Documentation Practices and a strong understanding of FDA regulations and guidelines. Participate in review of BabyBIG documentation to support highest possible quality of all records produced by manufacturing contractors or contracting research organizations .
Den-Mat Holdings LLCRegulatory Affairs Specialist Den-Mat Holdings LLCRegulatory Affairs SpecialistLompoc, CA$66,500–$90,802 / yearImplement and/or maintain systems and processes needed to ensure compliance with the receipt, storage and distribution of regulated products; as well as tracking distribution of prescription drugs and medical devices. Many factors go into determining employee pay within the posted range including education, prior experience, training, current skills, certifications, location/labor market, internal equity, etc.
SupplyBank.orgDirector of Regulatory Affairs and Policy SupplyBank.orgDirector of Regulatory Affairs and PolicyOakland, CA$115,000–$130,000 / yearThrough partnerships with global supply chains and community organizations, SupplyBank.org provides a highly cost-effective and scalable mechanism for bulk purchasing and efficiently distributing necessary health, education, and emergency supplies to children, families, and communities that need them throughout California. Of the total 100 acres, more than 80 will be revitalized park spaces, infrastructure improvements and nature based solutions to restore tidal wetlands, habitat, flood management and increase public enjoyment of the Bay Trail and parklands.
Edison InternationalNewUtility Regulatory Affairs Senior Advisor Edison InternationalUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
Natera IncRegulatory Affairs Advisor Natera IncRegulatory Affairs AdvisorSan Carlos, CA$146,100–$182,600 / yearCoordinates and prepares regulatory submissions with minimum supervision, including EU/IVD Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical registrations worldwide. Communication: Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; effective interactions with technical personnel (scientific and legal); and negotiate with Regulators.
Radiant Industries IncNewDirector of Regulatory Affairs Radiant Industries IncDirector of Regulatory AffairsEl Segundo, CACraft a modern regulatory strategy based in sound engineering principles with input from executives, our board of directors, and industry experts that brings the safest product to market the fastest. Portable nuclear power with rapid-deploy capability can replace similar-sized diesel generators and provide critical asset support for hospitals, data centers, remote sites, and military bases.
Applied MedicalAssociate Specialist – Premarket Regulatory Affairs Applied MedicalAssociate Specialist – Premarket Regulatory AffairsRancho Santa Margarita, California$70,000–$80,000 / yearEngage in regulatory strategy planning and change management for various markets, including Asia Pacific, Latin America, the European Union, and MENAT (Middle East North Africa). Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions.
Gulf Coast Automation GroupPrincipal Regulatory Affairs Specialist Gulf Coast Automation GroupPrincipal Regulatory Affairs SpecialistSan Jose, California$190,000–$210,000 / yearIt continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens. Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
Mirum PharmaceuticalsNewAssociate Director, Regulatory Affairs Advertising and Promotion Mirum PharmaceuticalsAssociate Director, Regulatory Affairs Advertising and PromotionSan Mateo, CA$205,000–$225,000 / yearManage and author commercial regulatory submissions, working closely with the Publishing vendor to ensure timely publishing and submission of promotional materials to the Office of Prescription Drug Promotion (OPDP). Bachelor's or advanced degree in a scientific discipline, with a minimum of 8 years in Regulatory Affairs with a minimum of 6 years of experience in the regulatory review of advertising and promotional materials for prescription drug and/or biologic products.
Iridex CorporationRegulatory Affairs - Post Market Surveillance Iridex CorporationRegulatory Affairs - Post Market SurveillanceMountain View, CA$75,000–$95,000 / yearPerform and document Complaint Handling, assessment, and reporting Receive and investigate product- and service-related communications / complaints, with communication received from various sources, including communications from field service management platforms (ServiceMax), customer relationship management platforms (SalesForce), enterprise resource planning platforms (Business Central), internal service records, and other direct and indirect customer/user communications. Regulatory Affairs (Associate / Specialist / Senior Specialist) Post Market Surveillance personnel are responsible for: (1) analyzing Post Market Surveillance (PMS) data to prepare Post Market Surveillance reports and documentation, and to update related risk and other documentation accordingly.
Dendreon CorporationNewAssociate Director, Regulatory Affairs Dendreon CorporationAssociate Director, Regulatory AffairsSeal Beach, CaliforniaWith Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation. 10+ years of progressive Regulatory Affairs experience within the biotechnology, pharmaceutical, or life sciences industry, including experience leading complex regulatory submissions and cross-functional initiatives.
Axis Talent PartnersNewLEGISLATIVE AND REGULATORY AFFAIRS DIRECTOR AT HOUSING CALIFORNIA Axis Talent PartnersLEGISLATIVE AND REGULATORY AFFAIRS DIRECTOR AT HOUSING CALIFORNIAElk Grove, CAWe bring together a diverse, cross-sector network to prevent and end homelessness, increase the supply of safe, stable, affordable homes, and reverse the legacy of systemic racial and economic inequities by building power among the people most impacted by housing injustice in partnership with cross-sector partners, shaping the narrative, and advocating for the passage of transformative statewide policy solutions. The position is expected to participate in regular travel (mostly in California) including the following engagements: twice yearly Board of Directors meetings (sometimes held in Sacramento); annual 2-3 day staff retreat; annual 3-day Housing California conference (often in Sacramento); annual 2-3-day statewide RUN summit (sometimes in Sacramento); plus various conferences or in-person partner meetings, based on need and interest.
Ascendis PharmaAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961 Ascendis PharmaAssociate Director, Global Regulatory Affairs Clinical Strategy - Job ID: 1961Palo Alto, CA$185,000–$205,000Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations. Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs?
Star TherapeuticsVP. Regulatory Affairs Star TherapeuticsVP. Regulatory AffairsSouth San Francisco, CA$276,000–$345,000Collaborate with cross-functional teams (Clinical Development, CMC, Quality Assurance) to ensure regulatory compliance throughout the development process and ensure cross-functional alignment during key steps across multiple projects simultaneously. We are seeking a strategic and results-oriented leader to oversee all regulatory activities for our hematology/immunology pipeline, with an initial focus on the upcoming Phase 3 clinical trial for our lead candidate, VGA039.
Allogene TherapeuticsAssociate Director, Regulatory Affairs Allogene TherapeuticsAssociate Director, Regulatory AffairsSouth San Francisco, CARemote$170,000–$210,000 / yearReporting to the Senior Director, Regulatory Affairs, this position will serve as a core regulatory representative on cross‑functional program teams, supporting interactions with global health authorities and ensuring regulatory strategies and submissions are aligned with evolving regulatory expectations for cell and gene therapies. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients.
Nihon KohdenNewRegulatory Affairs Specialist Nihon KohdenRegulatory Affairs SpecialistIrvine, CA$80,000–$100,000 / yearPhysical: Generally, may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, and color vision. Work with RA Leadership and other members of the RA team to set strategy for regulatory approval to introduce new products to market, evaluate regulatory requirements and prepare regulatory submissions.
BaRupOn LLCDirector of Licensing & Regulatory Affairs (SMR / MMR Programs) BaRupOn LLCDirector of Licensing & Regulatory Affairs (SMR / MMR Programs)Irvine, CABaRupOn LLC is seeking a highly experienced Director of Licensing & Regulatory Affairs to lead all regulatory strategy, licensing execution, and compliance activities for its Small Modular Reactor (SMR) and Micro Modular Reactor (MMR) programs in the United States. The ideal candidate brings deep, direct NRC engagement experience, a thorough command of U.S. nuclear regulatory frameworks, and the leadership ability to build and manage a high-performing regulatory team in a fast-moving, mission-driven environment.
Southern California EdisonNewUtility Regulatory Affairs Senior Advisor Southern California EdisonUtility Regulatory Affairs Senior AdvisorRosemead, CAIn this job, you'll be developing and advocating the Company's positions associated with wholesale generation and energy storage interconnections to SCE's distribution system, including managing the development of revisions to SCE's wholesale distribution access tariff. Become a Utility Regulatory Affairs Senior Advisor at Southern California Edison (SCE) and help meet our goals of interconnecting clean energy resources to SCE's grid.
GileadNewAssociate Director, Regulatory Affairs CMC GileadAssociate Director, Regulatory Affairs CMCSan Mateo, CAAt Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. Provide high level feedback to senior cmc management on points of discussion with regional regulatory authorities that may impact globally (detailed minutes are communicated by the regional regulatory leads).
AstraZeneca PlcSenior Regulatory Affairs Director - Oncology Cell & Gene Therapy AstraZeneca PlcSenior Regulatory Affairs Director - Oncology Cell & Gene TherapySouth San Francisco, CA$218,058.40–$327,087.60 / yearWorking with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide. Competitive salary and benefits package on offer: Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.
Truvian Sciences IncRegulatory Affairs Director Truvian Sciences IncRegulatory Affairs Directorsorrento, CA$168,000–$186,000 / yearThe ideal candidate must have extensive experience in the in vitro diagnostics (IVD) industry, with a strong track record of leading both FDA 510(k) and CLIA Waiver submissions through to successful clearance. Required QualificationsBachelor's degree in Life Sciences, Engineering, or a related discipline required; advanced degree (MS, PhD) strongly preferred.12+ years of experience in Regulatory Affairs, with a minimum of 8 years in the IVD industry.