Director - Quality Management & Regulatory Affairs Stanford Health CareDirector - Quality Management & Regulatory AffairsPalo Alto, California$89.01–$117.94 / hourReporting to the Executive Director for Quality, Patient Safety & Infection Prevention, the Director collaborates with cross-functional leaders and teams within Stanford Health Care and Stanford School of Medicine to develop and implement the quality assessment and performance improvement plan (QAPI).The key areas of responsibility include development and implementation of the tactics and communication plans which ensure that the organization is continually prepared for reliable care in accordance of accreditation, federal and state regulatory requirements. In this highly visible role, you'll partner with executive and clinical leaders, mentor high-performing teams, and drive the strategies that strengthen regulatory excellence, patient safety, and continuous readiness.
Regulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Director, Regulatory Affairs (US Filing Lead) Revolution Medicines, Inc.Director, Regulatory Affairs (US Filing Lead)Redwood City, CA$211,000–$264,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Director, Regulatory Affairs - US Filing Lead Revolution Medicines, Inc.Director, Regulatory Affairs - US Filing LeadRedwood City, CA$211,000–$264,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Required Skills, Experience and Education: Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including a regulatory strategy role.
Assoc Regulatory Affairs Strategy Director (Oncology) Exelixis Inc.Assoc Regulatory Affairs Strategy Director (Oncology)Alameda, CA$195,000–$277,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of eleven years of related experience; or, Master's degree in related discipline and a minimum of nine years of related experience; or, PhD degree in related discipline and a minimum of five years of related experience; or, Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: Knowledge/Skills: Develops and manages plans within established timelines and balances commitments to complete multiple activities and achieve results.
Regulatory Affairs Specialist 4 IconmaRegulatory Affairs Specialist 4Sunnyvale, CA$53.65–$58.65 / hourRequirements:Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
Regulatory Affairs Specialist 4 ICONMA, LLCRegulatory Affairs Specialist 4Sunnyvale, CA$55–$60 / hourRequirements: Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science). Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement.
NewDirector, Regulatory Affairs Lyell Immunopharma, Inc.Director, Regulatory AffairsSouth San Francisco, CA$210,000–$260,000 / yearIn our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response.
Senior Regulatory Affairs Specialist Procept BioroboticsSenior Regulatory Affairs SpecialistSan Jose, CA$148,550–$174,770 / 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.
Vice President, Regulatory Affairs InsitroVice President, Regulatory AffairsSouth San Francisco, CA$313,000–$333,000 / yearReporting directly to the Chief Medical Officer, you will develop and implement global regulatory strategies supporting multiple therapeutics - small molecules, biologics, and oligonucleotides - and diagnostics across our three therapeutic areas: neurology/neurodegeneration, metabolism/cardiovascular, and ophthalmology. You will be at the forefront of implementing and influencing new regulatory policy across multiple jurisdictions using objective, data-driven approaches, treating health authorities as key partners who share our vision of bringing better, more targeted drugs to patients faster.
VP Quality & Regulatory Affairs Nova Pneuma, Inc.VP Quality & Regulatory AffairsFremont, CAPart timeProvide executive oversight of Quality Assurance activities, including but not limited to: Quality Systems, Document Control, Training, Change Control, Deviations, CAPA (including timely implementation and closure), Audits (internal, external and supplier), Risk Management, and Product Release. 15+ years of progressive relevant senior regulatory and QA/QC experience, including at least 8 years executive level experience, in the Pharma biotechnology/pharmaceutical industry with direct regulatory affairs experience with drug/device combination products.
Director, Regulatory Affairs Cytokinetics, IncorporatedDirector, Regulatory AffairsSouth San Francisco, CA$225,000–$262,500 / yearCytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Qualifications: 10+ years of drug development, including at least 7+ years of regulatory affairs experience in the Biotech/Pharmaceutical industry; experience in small molecule drug development is preferred; experience in the cardiovascular therapeutic area is a plus.
Senior Manager, Regulatory Affairs - Lingo (on-site) AbbottSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, California$130,700–$261,300 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Senior Director, Regulatory Affairs Annexon, Inc.Senior Director, Regulatory AffairsSan Francisco, CARemote$265,000–$285,000 / yearResponsibilities include: Provides regulatory leadership in support of the development, registration, and life-cycle management of Annexon products by collaborating cross-functionally with Clinical Development, Clinical Operations, Medical Affairs, CMC, and Quality to develop, coordinate, and implement global regulatory strategies and submissions, including CTAs, for new and ongoing clinical studies. Responsibilities include developing and driving regulatory strategies and detailed plans to meet company objectives, participating in program core teams and governance forums, and managing interactions with regulatory agencies to support development and registration strategies.
Head Of Regulatory Affairs Health GPT IncHead Of Regulatory AffairsMenlo Park, CAHelp design, support, and maintain a compliant regulatory framework and Pharma-partner guidelines, including iterative AI development, model updates, QMS and GMP requirements, audits and inspections, real-world performance, and post-market monitoring and mitigation. We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children's, WellSpan Health, John Doerr, Rick Klausner, and others.
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.
Senior Regulatory Affairs Specialist LancesoftSenior Regulatory Affairs SpecialistSanta Clara, CA$43.80Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies as required.
Director, Regulatory Affairs CMC - Cell Therapy & Novel Therapeutics RetroDirector, Regulatory Affairs CMC - Cell Therapy & Novel TherapeuticsRedwood City, CAAs one of the earliest members of the Regulatory Affairs team, you will work across Retro’s programs and play a leading role in building out the regulatory CMC capabilities and strategies to achieve our ambitious mission and tackle aging. You have high-collaboration and low-ego tendencies, with the ability to align cross-functional technical teams and external partners around a shared regulatory CMC plan and clear deliverables.
Senior Regulatory Affairs Specialist – Heart Failure (on-site) AbbottSenior Regulatory Affairs Specialist – Heart Failure (on-site)Pleasanton, California$90,000–$180,000 / yearThe individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.
Senior Regulatory Affairs Specialist - Lingo (on-site) AbbottSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, CaliforniaIn this role, you will provide regulatory input on design and development activities to cross-functional teams, including software development and systems engineering members, and ensure availability of documentation to support submission activities to meet program objectives and timelines. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities to commercialize new digital products and features including generative AI technologies designed to help millions of patients in the US.