Senior Director, Regulatory Affairs (Oncology) Exelixis Inc.Senior Director, Regulatory Affairs (Oncology)Alameda, CA$248,000–$352,500 / yearEDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or, Master's degree in related discipline and a minimum of thirteen years of related experience; or, PhD degree in related discipline and a minimum of twelve years of related experience; or, Equivalent combination of education and experience. Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
Global Head of Government Affairs ZiplineGlobal Head of Government AffairsSan Francisco, CA$250,000–$300,000 / yearYou'll design and execute Zipline's government affairs and public affairs strategy, with the support of the world-class team you build and lead, and you'll have a direct impact on scaling Zipline's business across the United States, building on our broad footprint in Africa, and launching new markets abroad. Develop and maintain networks of community advocates, including business and civic leaders, former public officials, users and merchants, first responders, academics, faith leaders, healthcare organizations, environmental and road-safety groups, and workforce organizations.
Director - Quality Management & Regulatory Affairs Stanford Health CareDirector - Quality Management & Regulatory AffairsPalo Alto, CA$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). 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.
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 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.
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.
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.
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.
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.
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.
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.
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.
Project Manager Clinical Affairs eTeam Inc.Project Manager Clinical AffairsSunnyvale, CARemote$87–$88 / hourAs a key cross-functional partner, this role will collaborate closely with Regulatory Affairs, Quality Compliance, Program Management, Clinical Affairs, Post-Market Surveillance, Regulatory Compliance, Training, Legal, and other stakeholders to strengthen inspection readiness, support compliance execution, and enable achievement of business and clinical quality objectives. Partner with internal stakeholders to develop internal processes, KPIs and drive identified initiatives, Support the development and execution of a proactive, risk-based clinical quality and compliance program that safeguards participant safety, supports data integrity, and promotes continuous improvement across all clinical studies.
Director, Clinical Affairs Noctrix HealthDirector, Clinical AffairsPleasanton, California$240,000–$280,000 / yearThis individual will provide leadership across clinical operations, including sponsor oversight, site management, CRO and vendor management, clinical data quality, study execution, and evidence generation. The Director, Clinical Affairs will serve as a key cross-functional leader and liaison among Clinical Affairs, Clinical Research, Regulatory Affairs, Quality, Product Development, and external partners.
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.
NewSenior Regulatory Affairs Specialist - Lingo (on-site) AbbottSenior Regulatory Affairs Specialist - Lingo (on-site)Alameda, California$90,000–$180,000 / yearIn 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.
Senior Regulatory Affairs Specialist – Lingo (on-site) AbbottSenior Regulatory Affairs Specialist – Lingo (on-site)Alameda, California$90,000–$180,000 / yearIn 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. Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class II software medical devices.