District Human Resources Manager - San Diego Penske Truck RentalDistrict Human Resources Manager - San DiegoSAN DIEGO, CA$70,304–$93,500 / yearIf you have HR functional experience and skills, e.g., managing associate performance, leading difficult discussions, developing associates, ability to anticipate evolving business, we are interested in hearing from you, including if this experience was gained during time spent in a Penske operational role. The District Human Resources Manager is a valued member of the Human Resources and Field Operations teams, reporting directly to the District Manager, with a dotted line to the Area Human Resources Manager who aligns with Field Operations and corporate HR.
NewSenior Accounting Manager Vaco LLCSenior Accounting ManagerSan Diego, CATitle: Senior Manager, Technical Accounting Company: Innovative Biotechnology Organization Compensation: $150-175k base salary + bonus + equity + comprehensive benefits Overview: An innovative biotechnology company is seeking a Senior Manager of Technical Accounting to join its finance organization. Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs.
NewPayroll Manager Vaco LLCPayroll ManagerSan Diego, CARemote$95,000–$125,000 / yearTitle: Payroll Manager Company Industry: Healthcare / Behavioral Health Compensation: $95,000-$125,000 Location: Remote (strong preference for someone based out of CA) A client of ours is seeking a Payroll Manager to lead end to end payroll operations in a multi site, high touch environment. Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs.
NewAccounting Manager Vaco LLCAccounting ManagerSan Diego, CA$60–$72 / hourDetermining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Title: Accounting Manager Company: Construction Industry Compensation: $60-72/hr (DOE) Key Responsibilities: Lead and develop a team of three accounting professionals while overseeing day-to-day accounting operations, including AP, payroll, general ledger, and financial reporting.
Registered Nurse / Clinical Manager, Home Health AccentCare, Inc.Registered Nurse / Clinical Manager, Home HealthSan Diego, CA$110,000–$135,000 / yearThis includes the coordination and management of patient care, and the supervision and coaching of clinical personnel to ensure that care and services are delivered appropriately. If you meet these qualifications, we would love to meet you: Graduate from an approved school of professional nursing and currently licensed to practice as a registered nurse in the state of agency operation.
Registered Nurse / Patient Care Manager, Home Health AccentCare, Inc.Registered Nurse / Patient Care Manager, Home HealthSan Marcos, CA$110,000–$135,000 / yearWhat You Need to Know: The Patient Care Manager plays a critical role in supporting both patients and the caregiving team, ensuring that every person receives compassionate, high‑quality home health services. By guiding and empowering clinical staff, the Patient Care Manager helps create a supportive environment where employees can grow, collaborate, and deliver their very best work, ultimately enriching the care experience for every patient.
Insurance Unit Manager/Supervisor GEICOInsurance Unit Manager/SupervisorPoway, CA$77,900–$133,250 / yearBachelor's or Associate's degree with 2+ years of supervisory experience OR a minimum of 4 years of supervisory experience in lieu of a degree (high school diploma or equivalent required). Factors include, but are not limited to, the scope and responsibilities of the role, the selected candidate’s work experience, education and training, the work location as well as market and business considerations.
NewProgram Manager - The Sharp University Learning Programs - Full Time - Hybrid SHARP HEALTHCAREProgram Manager - The Sharp University Learning Programs - Full Time - HybridSan Diego, CA$72,000–$86,400 / year5 Years experience designing, developing, and implementing large scale training programs; inclusive of project or program management in developing leadership skills, knowledge, and workforce development. See Sharp HealthCare Terms & Conditions at https://www.sharp.com/patient-rights-privacy/terms-of-use.cfm and Privacy Policy at https://www.sharp.com/patient-rights-privacy/privacy-practices.cfm and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions.
Construction Manager Lennar HomesConstruction ManagerSan Diego, CA$68,640–$98,473 / yearFull timeLennar is one of the nation's leading homebuilders, dedicated to making an impact and creating an extraordinary experience for their Homeowners, Communities, and Associates by building quality homes and providing exceptional customer service, giving back to the communities in which we work and live in, and fostering a culture of opportunity and growth for our Associates throughout their career. Tech-savvy with proficiency in Microsoft Office, Build Pro, Procore, and other construction management software, leveraging technology to streamline workflows, enhance project tracking, and improve overall efficiency.
NewSenior Manager, QA & Regulatory Affairs Agena Bioscience Inc.Senior Manager, QA & Regulatory AffairsSan Diego, CA$154,500–$193,250 / yearPart timeThe Senior Manager leads cross-functional quality and regulatory initiatives, manages audit readiness and regulatory submissions, and develops a high-performing team that supports business objectives and global compliance requirements. The Senior Manager, Quality & Regulatory Affairs is responsible for overseeing the development, implementation, and continuous improvement of the organization’s Quality Management System (QMS) and Regulatory Affairs programs.
NewSenior Manager, QA & Regulatory Affairs Mesa Laboratories IncSenior Manager, QA & Regulatory AffairsSan Diego, CA$154,500–$193,250 / yearJob Summary: The Senior Manager, Quality & Regulatory Affairs is responsible for overseeing the development, implementation, and continuous improvement of the organization's Quality Management System (QMS) and Regulatory Affairs programs. The Senior Manager leads cross-functional quality and regulatory initiatives, manages audit readiness and regulatory submissions, and develops a high-performing team that supports business objectives and global compliance requirements.
Senior Manager, CMC Regulatory Affairs (Biologics) Travere Therapeutics IncSenior Manager, CMC Regulatory Affairs (Biologics)San Diego, CARemote$132,000–$172,000 / yearThe Senior Manager serves as the primary CMC Regulatory Affairs representative on cross-functional teams and partners closely with Technical Operations, Process Development, Pharmaceutical Development, Manufacturing, Quality, Analytical Development, Supply Chain, Regulatory Operations, and Project Management to ensure alignment of CMC development plans with global regulatory requirements and business objectives. This role leads the development and execution of global CMC regulatory strategies to support clinical development, marketing applications, and lifecycle management activities for biologic products, with a strong focus on late-stage development, Phase 3 programs, and rare disease therapeutics.
Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxRegulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)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. 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.
Senior 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.
Senior Regulatory Affairs Specialist - Manager Synaptic Medical LLCSenior Regulatory Affairs Specialist - ManagerCarlsbad, CAKey responsibilities: Lead the regulatory strategy for new product development and market entry, including 510(k), PMA, and CE Mark submissions. What we are looking for: Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree a plus).
Manager, Regulatory Affairs Strategy Travere Therapeutics IncManager, Regulatory Affairs StrategySan Diego, CARemote$116,000–$151,000 / yearPosition Summary: The Manager, Regulatory Affairs provides regulatory leadership and execution support for late-stage development programs and contributes to the implementation of global regulatory strategies from development through registration and lifecycle management activities. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.
Associate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking) CorDxAssociate Regulatory Affairs Manager (San Diego) - Bilingual (Mandarin Speaking)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 Associate Manager will work cross-functionally with internal teams and external partners to support product approvals and maintain regulatory compliance throughout the product lifecycle.
Sr. Regulatory Ad Promo Manager Neurocrine Biosciences Inc.Sr. Regulatory Ad Promo ManagerSan Diego, CA$158,100–$216,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids , as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Navigates complex cross-functional discussions and operates independently while appropriately seeking strategic alignment on highly complex, novel, or high-risk issues.
Sr Manager/Assoc Director, CMC Regulatory Affairs ErascaSr Manager/Assoc Director, CMC Regulatory AffairsSan Diego, CAAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
Sr Manager/Assoc Director, CMC Regulatory Affairs Erasca IncSr Manager/Assoc Director, CMC Regulatory AffairsSan Diego, CA$175,000–$205,000 / yearAssess proposed CMC changes (e.g., manufacturing processes, analytical methods, specifications, manufacturing sites, container closure systems, stability programs, and suppliers) and support development of appropriate global regulatory filing strategies. Position Responsibilities: Deliver CMC regulatory support through QC review of submission components, including CMC documents, labeling, application forms, supporting GMP documentation, cover letters and verification of submission links, ensuring completeness, consistency, and compliance with regulatory requirements.
Regulatory Manager- IVD and 510(k) CorDxRegulatory Manager- IVD and 510(k)San diego, CA$90,000–$150,000 / yearWith 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. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Regulatory Strategy Manager Neurocrine Biosciences IncRegulatory Strategy ManagerSan Diego, CA$132,700–$182,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids , as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Requirements: BS/BA degree in Life/Health Sciences AND 6+ years of industry experience of which a minimum of 3 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a lead capacity.
NewSenior Regulatory Compliance Manager Circle Internet Financial LLCSenior Regulatory Compliance ManagerSan Diego, CARemote$172,500–$222,500 / yearWhat you'll be responsible for: Circle is looking for a Senior Manager to join the Regulatory Assurance team who will help to create a central global function focused on developing a best in class compliance management system, supporting all regional and core compliance team functions. Circle's platform includes the world's largest regulated stablecoin network anchored by USDC, Circle Payments Network for global money movement, and Arc, an enterprise-grade blockchain designed to become the Economic OS for the internet.
Litigation Marketing Senior Manager - Regulatory Cooley LLPLitigation Marketing Senior Manager - RegulatorySan Diego, CA$170,000–$240,000 / yearSpecific duties and responsibilities include, but are not limited to, the following: Position responsibilities: Strategic planning and leadership: In conjunction with the Associate Director or Director of Marketing (Business/Litigation), department and practice group leaders, develop and execute marketing and business development plans for assigned practice group(s)/industries/verticals, and individual partners within those groups. In this leadership role, the Senior Practice Group Marketing Manager will interact with practice group leaders and partners in devising marketing and client development programs in a manner consistent with the firm's overall strategy.
Principal Product Compliance Manager - Money Transmission & Regulatory Compliance Intuit IncPrincipal Product Compliance Manager - Money Transmission & Regulatory ComplianceSan Diego, CA$207,500–$281,000 / yearThis person will operate as a senior compliance expert and collaborative cross-functional partner, exercising broad influence across product, engineering, legal, and business functions, while serving as a key participant in regulatory examinations and driving proactive exam readiness. Broad working knowledge of adjacent regulatory domains - including AML/BSA, OFAC/sanctions compliance, financial reporting obligations, and bank partnership risk - sufficient to navigate, advise, and identify cross-domain risk without dependency on dedicated program owners.
Sr Regulatory Affairs Specialist DexComSr Regulatory Affairs SpecialistSan Diego, CaliforniaRegulatory Affairs Specialist will be responsible for supporting product classifications, change assessments, registration and approval for software products, including mobile applications, AI/ML enabled data products, cloud-based solutions and cybersecurity initiatives. You are the RA representative on core functional teams for global software regulatory classification, change management, and regulatory submissions including: US 510(k), pre-submissions, LTF, MDDS change assessment.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationSan Diego, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
Regulatory Affairs Specialist DexComRegulatory Affairs SpecialistSan Diego, CaliforniaWith our various backgrounds and talents we help to navigate and align the ideas and output of most facets of the company to successfully get our home-use products to our end users. You bring knowledge of US and international regulatory requirements including design control, medical device submission requirements, labeling and promotion regulations, and medical device quality systems.
Head of Global Regulatory Affairs (U.S. Remote) Adagene IncorporatedHead of Global Regulatory Affairs (U.S. Remote)San Diego, CARemoteMust have extensive knowledge of regulatory requirements, including ICH GCP, GMP, GLP, and regional requirements and understand current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business. As a Head of Global Regulatory Affairs this person will perform a critical role in strategies, documentations, submissions, and company interactions to regulatory authorities such as FDA, CFDA, and other regulatory agencies.
Regulatory Affairs Specialist Quidelortho CorpRegulatory Affairs SpecialistSan Diego, CAQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Regulatory Operations provides infrastructure to the broader department through the creation and continuous improvement of regulatory processes, implementation and maintenance of regulatory software systems, and management of centralized regulatory services and support functions.
Senior Regulatory Affairs Specialist DexCom IncSenior Regulatory Affairs SpecialistSan Diego, CA$91,400–$152,300 / yearMeet the team: Join our world-class regulatory team and play a key role in bringing Dexcom's innovative products to markets worldwide. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com.
Senior Director, Global Regulatory Affairs Janux TherapeuticsSenior Director, Global Regulatory AffairsSan Diego, CaliforniaThis role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment.
Senior Director, Global Regulatory Affairs Janux Therapeutics Inc.Senior Director, Global Regulatory AffairsSan Diego, CA$240,000–$275,000 / yearThis role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment.
Senior Director, Global Regulatory Lead Neuroscience Bristol Myers SquibbSenior Director, Global Regulatory Lead NeuroscienceSan Diego, CA$258,680–$313,460 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products: Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.
NewRegulatory Affairs Specialist 3 - Medical Device IVD YohRegulatory Affairs Specialist 3 - Medical Device IVDSan Diego, CA$105,800–$132,250 / yearThe Regulatory Affairs Specialist III will develop and execute regulatory strategies, prepare complex regulatory submissions, collaborate with cross-functional teams, and serve as a regulatory subject matter expert to support new product development and post-market activities. This role requires strong technical expertise, regulatory knowledge, and the ability to influence stakeholders while ensuring compliance with FDA, EU, and international regulatory requirements.
Director, Regulatory Affairs Strategy Travere Therapeutics IncDirector, Regulatory Affairs StrategySan Diego, CARemote$189,000–$246,000 / yearPosition Summary: The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical development, registration, and commercialization of investigational products. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Director / Senior Director Of Regulatory Operations Artiva BiotherapeuticsDirector / Senior Director Of Regulatory OperationsSan Diego, CA$205,000–$268,000 / yearThe ideal candidate will bring deep expertise in eCTD submissions, regulatory information management systems, and cross-functional project leadership in a fast-paced biotech environment, with preference for experience in cell therapy or biologics. Partner with Regulatory Affairs Leads, Clinical Development, CMC, Pharmacovigilance, Project Management and Program Lead to develop and maintain integrated regulatory project plans, timelines, and risk mitigation strategies.
Associate Director, Regulatory and Medical Writer Ionis Pharmaceuticals IncAssociate Director, Regulatory and Medical WriterCarlsbad, CARemote$142,588–$201,472 / yearRESPONSIBILITIES: Working with the Executive Director, Regulatory and Medical Writing, lead the development, authoring, and delivery of complex regulatory documents such as clinical study reports and marketing application summary documents (Module 2), and lead and/or contribute to Investigator's Brochures, clinical study protocols, and briefing documents. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.
NewAssociate Director / Director, Regulatory Affairs - CMC Iambic TherapeuticsAssociate Director / Director, Regulatory Affairs - CMCSan Diego, CaliforniaThis individual will partner closely with Technical Operations, Process Chemistry, Analytical Development, Formulation, Manufacturing, Quality, Clinical, Nonclinical, Regulatory Operations, and external partners, and will support interactions with the US FDA and other global health authorities as appropriate. Monitor global CMC regulations, identify CMC regulatory risks, gaps, and dependencies; develop mitigation strategies and communicate collected intelligence, precedence and potential impacts on program timelines, submission plans, and product development decisions.
Director Regulatory Affairs - CMC Clinical Dynamix, Inc.Director Regulatory Affairs - CMCSan Diego, CAResponsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.
Director, Regulatory Affairs Labeling Arrowhead Pharmaceuticals IncDirector, Regulatory Affairs LabelingSan Diego, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Director, Regulatory Affairs (Labeling) Arrowhead PharmaceuticalsDirector, Regulatory Affairs (Labeling)San Diego, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Senior Director, Regulatory Affairs-CA Synchron IncSenior Director, Regulatory Affairs-CASan Diego, CA$210,000–$240,000 / yearThis role will own regulatory strategy for new BCI platform development, with oversight of ongoing product updates, and manufacturing-related submissions, working closely with cross-functional teams in engineering, quality, and clinical to ensure regulatory readiness at every stage of the product lifecycle. We are seeking a Senior Director of Regulatory Affairs will serve as the senior regulatory leader for Synchron's San Diego operations, providing strategic and operational oversight across software, firmware, and hardware regulatory activities.
Senior Spectrum Engineer, Regulatory Affairs Viasat, Inc.Senior Spectrum Engineer, Regulatory AffairsCarlsbad, California$180,500–$285,000 / yearFull timeFor specific work locations within San Jose, the San Francisco Bay area and New York City metropolitan area, the base pay range for this role is $224,500.00- $336,500.00/ annually: At Viasat, we consider many factors when it comes to compensation, including the scope of the position as well as your background and experience. Multi-Orbit & Next-Gen Architecture: Deep technical understanding of non-geostationary (NGSO) constellation dynamics, spectrum sharing paradigms, or emerging satellite-to-cell (Direct-to-Device) frameworks.
Consultant, Global Regulatory Affairs Cullgen IncConsultant, Global Regulatory AffairsSan Diego, CAPosition Summary: Our ideal Consultant will bring a high level of strategic thinking paired with a get-things-done attitude, and the ability to apply their experience to manage risk and drive programs forward in a small-company environment. Requirements: 15+ years of industry experience in running global clinical regulatory operations and related activities in addition to successful track record as a regulatory consultant required.
NewManager, Quality Control Thermo Fisher Scientific IncManager, Quality ControlCarlsbad, CA$103,100–$135,000 / yearLeverage laboratory performance data and quality trends, including out-of-specification (OOS) results, laboratory deviations, and testing metrics, to identify risks and opportunities, drive deeper investigation when warranted, and partner with cross-functional teams to improve product quality, laboratory performance, and customer outcomes. Lead, develop, and manage the QC laboratory team, including supervisors and team leads, ensuring effective laboratory operations, building team capability, and driving consistent execution of quality control and testing priorities across multiple product lines.
Senior Manager, Reference Standards & Reagents Vera Therapeutics IncSenior Manager, Reference Standards & ReagentsSan Diego, CA$125,000–$185,000 / yearVera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Vera Therapeutics' receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Sr. Manager, Medical Writing Artiva Biotherapeutics IncSr. Manager, Medical WritingSan Diego, CA$165,000–$180,000 / yearDUTIES/RESPONSIBILITIES: Author clinical and regulatory documents, including clinical study protocols and amendments, Investigator Brochures, lab manuals, annual reports (e.g., DSURs/IND annual reports), clinical study reports, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, and BLAs/MAAs as applicable). The ideal candidate brings practical experience leading and preparing clinical and regulatory documents, a working knowledge of ICH/GCP and global regulatory expectations, and the ability to deliver clear, scientifically rigorous documents on tight timelines.
Sr. Manager, QA Aspen Neuroscience IncSr. Manager, QASan Diego, CA$160,000–$186,000 / yearTotal Rewards and Culture: Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. SUMMARY: The Senior Manager, Quality Assurance leads the execution, maintenance, and ongoing improvement of GxP quality systems and teams that support Phase 2a through Phase 3 clinical and manufacturing operations.
Manager, Compliance Engineering Tandem Diabetes Care IncManager, Compliance EngineeringCA$141,800–$177,300 / yearSTAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. The Manager, Compliance Engineering Drives Product Compliance Through Testing Excellence and is also responsible for; Lead compliance testing and certification activities for new products and product modifications.