Manager, Regulatory Affairs, Regulatory PMO Google LLCManager, Regulatory Affairs, Regulatory PMOMountain View, CAOversee and lead a team partnering with legal counsel, product teams, and other cross-functional stakeholders to drive strategy, share information, and implement program management principles across our largest and most complex matters (including litigation, internal investigations, and regulatory requests). Lead the development of project, program, and portfolio management methodologies, identifying opportunities for cross-organizational process improvement initiatives and knowledge management projects.
Regulatory Affairs Associate Jess BusheyRegulatory Affairs AssociateMountain View, California$75,000–$95,000Coordinate and maintain regulatory documentation, including preparation for local and regional registrations, license renewals, and product submissions. This role is pivotal in ensuring compliance with various global regulations, including FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR).
Regulatory Affairs Associate Heluna HealthRegulatory Affairs AssociateSan Francisco, CaliforniaUnder the direction of Susan Buchbinder, MD, Bridge HIV has been conducting HIV and STI preventive vaccine studies, HIV pre-exposure prophylaxis (PrEP) studies (including oral and injectable medications), and other studies of biomedical HIV prevention strategies since the early days of the epidemic. The Bridge HIV Investigators are global leaders in HIV vaccine and prevention science, epidemiology of HIV infection, HIV medication adherence, combination HIV prevention strategies, and HIV research training methods.
Senior Director, Regulatory Affairs Policy, Regulatory Intelligence & Compliance Exelixis IncSenior Director, Regulatory Affairs Policy, Regulatory Intelligence & ComplianceAlameda, CAThe position oversees the surveillance, triage, interpretation, and dissemination of global regulatory intelligence across Research & Development (R&D), Quality (QA), Information Technology (IT) and Pharmaceutical Supply Chain (PSC), partnering with cross-functional subject matter experts to ensure impact assessments are conducted and documented. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BA/BA degree in related discipline and 15 years of related experience; or, MA/MA degree in related discipline and 13 years of related experience; or, PhD in related discipline and 12 years of related experience; or, Equivalent combination of education and experience.
Regulatory Affairs Associate (Principal) - Medical Devices Apple IncRegulatory Affairs Associate (Principal) - Medical DevicesCupertino, CAThis role will involve assessment of regulatory impact for new and modified Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans in the US and globally. You will represent the RA/QA team on a diverse array of regulatory initiative teams and new product development, with the goal of obtaining approvals for new technologies.
Associate Director, Regulatory Affairs (Onsite in S.SF – 3X/wk) Zai Lab LtdAssociate Director, Regulatory Affairs (Onsite in S.SF – 3X/wk)South San Francisco, CA$198,000–$257,000 / yearProfessional Conduct: Execute responsibilities with professionalism, integrity, and attention to detail while working effectively across time zones and supporting a collaborative team environment.\n \nQualifications\n \nREQUIRED:\n\n Bachelor's degree in life sciences with 10 years' experience in the biopharmaceutical industry of which 8 years are in regulatory affairs; or equivalent combination of education, training, and experience\n \nPREFERRED:\n\n Advanced degree in life sciences, pharmacy, or a related field (MS, PhD, PharmD, or equivalent).\n Regulatory Guidance: Provide day\u2011to\u2011day clinical regulatory guidance to cross\u2011functional teams by interpreting regulations, policies, and guidance documents and applying them to program activities, including providing regulatory input into clinical development documents such as protocols, Investigator's Brochures, and study reports to ensure alignment with regulatory expectations.\n
Vice President, Regulatory And Head Of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory And Head Of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimet's cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Position Summary: The VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance for Sagimet.
Vice President, Regulatory and Head of Regulatory Affairs Sagimet Biosciences IncVice President, Regulatory and Head of Regulatory AffairsSan Mateo, CA$340,000–$370,000 / yearThis role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimets cross-functional teams and external partners, to ensure the successful advancement of our clinical programs. Oversee the companys external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the companys development programs.
Director, Regulatory Affairs (Strategy, I&I) Nurix Therapeutics, Inc.Director, Regulatory Affairs (Strategy, I&I)Brisbane, CAThis role will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Compliance Manager, Licensing & Regulatory Affairs Felix TechnologiesCompliance Manager, Licensing & Regulatory AffairsSan Francisco, CaliforniaWe are a hyper-growth Series C company, backed by over $200 million in funding from top-tier global investors, including QED, Castle Island, Switch Ventures, HTwenty, Monashees, and Andreessen Horowitz with support from General Catalyst Customer Value Fund. This individual will own the day-to-day management of Felix’s licensing portfolio, support expansion into new jurisdictions and products, and serve as the primary coordinator for regulator communications, examinations, and licensing-related projects.
Sr Manager/Assoc Director, CMC Regulatory Affairs Erasca IncSr Manager/Assoc Director, CMC Regulatory AffairsSouth San Francisco, 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.
Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors) Nurix Therapeutics, Inc.Director / Sr. Director, Regulatory Affairs (Strategy, Oncology Solid Tumors)Brisbane, CA$232,000–$274,000 / yearThis role will be responsible for developing and executing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy, guiding and executing compliant, high quality, nonclinical and clinical submissions and interactions in support of registration and life cycle management activities. Works strategically with all regulatory functions to develop detailed, actionable submission plans, tracks major submission deliverables, and ensures consistent management submission documents, health authority communications, and all other regulatory information supporting Nurix's investigational and marketing applications.
Associate Director, Regulatory Affairs Advertising And Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising And PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: 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. Manage 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).
Associate Director, Regulatory Affairs Advertising and Promotion Mirum Pharmaceuticals IncAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, CA$205,000–$225,000 / yearEducation /Experience: 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. Manage 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).
Manager, Regulatory Affairs iRhythm TechnologiesManager, 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.
Director, Global Regulatory Affairs Advertising & Promotion Mirum Pharmaceuticals IncDirector, Global Regulatory Affairs Advertising & PromotionFoster City, CA$240,000–$260,000 / yearThe individual is expected to work with a high degree of independence, accountability, reliability, and follow-through; proactively identify and resolve issues; anticipate risks to timelines or execution; and drive assigned activities to completion with limited day-to-day supervision. Establish and maintain an effective tracking and planning system, including materials under review, upcoming deliverables, regulatory submissions, key milestones, deadlines, dependencies, and outstanding actions, to support visibility, prioritization, and timely execution.
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemote$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.
Senior Regulatory Affairs Specialist Iovance Biotherapeutics IncSenior Regulatory Affairs SpecialistSan Carlos, CARemote$140,000–$160,000 / yearWorks with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. Mental: 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.
Sr Director, Regulatory Affairs RezoluteSr Director, Regulatory AffairsRedwood City, CaliforniaAs Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders. Reporting to the Chief Regulatory Officer, the Sr Director of Regulatory Affairs will join the regulatory team providing strategic and operational leadership supporting late-stage clinical development through regulatory submission, approval, and product launch.
Associate Director, Regulatory Affairs Cytokinetics, IncorporatedAssociate Director, Regulatory AffairsSouth San Francisco, CA$200,700–$234,150 / 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. Reporting to the Executive Director, Regulatory Affairs, the Associate Director, Regulatory Affairs, is responsible for hands-on regulatory activities across development stages, ensuring high-quality submissions and effective interactions with health authorities.