Director Of Regulatory Affairs And Quality Assurance (RA / QA) Eight SleepDirector Of Regulatory Affairs And Quality Assurance (RA / QA)San Francisco, CAEvery role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isn't passive, it's a powerful tool for living better. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies.
Director of Regulatory Affairs and Quality Assurance (RA / QA) Eight SleepDirector of Regulatory Affairs and Quality Assurance (RA / QA)San Francisco, CaliforniaEvery role at Eight Sleep is a chance to create cutting-edge technology, collaborate with world-class talent, and help shape a future where sleep isn't passive, it's a powerful tool for living better. This role will provide leadership for risk management and oversee the operation of the quality management system, as well as serve as the primary interface between our company and regulatory agencies.
Regulatory Affairs Strategy Director Roth Staffing CompaniesRegulatory Affairs Strategy DirectorAlameda, California$133.33–$153.33 / hourBachelor's degree in related discipline and a minimum of thirteen years of related experience; or, · Master's degree in related discipline and a minimum of eleven years of related experience; or, · PhD degree in related discipline and a minimum of eight years of related experience; or, · Equivalent combination of education and experience. Leads the systematic collection, analysis, and dissemination of regulatory intelligence to proactively inform our client's policies, processes, and practices, enabling subject matter experts to assess the impact of evolving global regulatory requirements and translate regulatory changes into actionable guidance.
(Senior) Manager, Regulatory Affairs Braveheart Bio(Senior) Manager, Regulatory AffairsSan Francisco, California$119,000–$190,000 / yearOur lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross‑functional deliverables and manage health authority queries and responses.
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.
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.
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.
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 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.
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.
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 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.
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.
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.
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.
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.
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.