Senior Manager/Associate Director, Environmental Affairs CYPRESS CREEK RENEWABLES, LLCSenior Manager/Associate Director, Environmental AffairsSan Francisco, CAProvide subject matter expertise support during financing, which would include responding to Independent Engineers and external legal counsel comments, advising on contractual terms and conditions for environmental risk, and supporting internal legal, tax, and finance teams to compile environmental documentation. Directly oversee scoping and managing complex, environmental regulatory compliance processes, such as targeted environmental resource studies (e.g., wetland delineations, Phase I ESAs, cultural resource surveys), environmental permitting, and mitigation negotiation, within the Company and with outside consultants.
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.
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 - US Filing Lead Revolution MedicinesDirector, Regulatory Affairs - US Filing LeadRedwood City, CaliforniaThe 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. 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 MedicinesDirector, Regulatory Affairs (US Filing Lead)Redwood City, CaliforniaThe 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. 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 of Regulatory Affairs Epia NeuroDirector of Regulatory AffairsAlameda, CaliforniaWe're looking for a Director of Regulatory Affairs, based in our Alameda, California office, to own the regulatory strategy and execution for Epia Neuro's Class III implantable neurotechnology - end-to-end, from early FDA engagement through IDE and PMA submission, approval, and commercialization. Partner directly with engineering on design and software decisions during active development, not reviewing after the fact, and help cross-functional alignment across development, clinical, quality, and operations to ensure activities support the regulatory strategy and requirements.
Public Policy Expert - Regulatory Affairs MercorPublic Policy Expert - Regulatory AffairsSan Francisco, CaliforniaRemote$50–$60 / hourInclude proposed and final rule text, regulatory impact discussion, and compliance determinations. A relevant credential or degree ( MPP , MPA , JD , CFCM/CPCM , PMP , or comparable).
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.
Director, Government Affairs & Public Policy HarveyDirector, Government Affairs & Public PolicySan Francisco, California$260,000–$350,000 / yearA career defined by progressive depth in public policy, government affairs, or regulatory work — whether in-house at a major technology or professional services company, in senior government or regulatory roles, or in a senior advisory capacity at a leading firm. You will develop and cultivate collaborative relationships with policy makers around the world, bringing a candid, well-informed perspective on the future of the legal profession and the policy positions best aligned with fostering and supporting a vibrant, resilient legal ecosystem.
Senior Director & Therapeutic Area Head, Regulatory Affairs Revolution Medicines, Inc.Senior Director & Therapeutic Area Head, Regulatory AffairsRedwood City, CA$232,000–$290,000 / 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 regulatory strategy and leadership roles.
Head of Regulatory Affairs Remedy RoboticsHead of Regulatory AffairsSan Francisco, CaliforniaExceptional written and verbal communication skills, with the ability to develop submission-quality narratives, present to executive leadership and boards, and effectively engage cross-functional technical stakeholders. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location.
Director, Regulatory Affairs Companion Diagnostics (Cdx) Revolution Medicines, Inc.Director, Regulatory Affairs Companion Diagnostics (Cdx)Redwood City, CA$201,000–$251,000 / yearRequired Skills, Experience and Education: Advanced degree or bachelor's degree in life sciences, molecular biology, biomedical engineering, pharmacy, medicine, or related scientific discipline with a minimum of 12+ years of pharmaceutical, biotechnology, diagnostics, or combination product experience, including at least 8 years in Regulatory Affairs supporting companion diagnostics or in vitro diagnostics. This individual will serve as the regulatory lead for companion diagnostic development programs, partnering closely with Clinical Development, Translational Medicine, Biomarker Sciences, Regulatory Science, Commercial, and external diagnostic partners to ensure successful co-development and global registration of therapeutic products and associated companion diagnostics.
Principal Regulatory Affairs Specialist – Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist – Diabetes Care (on-site)Alameda, California$100,000–$200,000 / yearThis is an exciting opportunity with responsibilities for leading global regulatory submissions, which include but not limited to premarket submissions, pre-submissions and clinical trial applications, which include medical hardware and digital health technology solutions to address the spectrum of customer needs. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Principal Regulatory Affairs Specialist - Diabetes Care (on-site) AbbottPrincipal Regulatory Affairs Specialist - Diabetes Care (on-site)Alameda, California$100,000–$200,000 / 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. The individual may monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory submission strategy, and provide executive management with regulatory metrics/information.
Vice President, Medical Affairs - Hematology-Oncology Nurix Therapeutics, Inc.Vice President, Medical Affairs - Hematology-OncologyBrisbane, CA$348,000–$399,000 / yearNurix Therapeutics is seeking a Vice President, Medical Affairs, Hematology-Oncology to build, expand, and lead a best-in-class Medical Affairs organization supporting the company's transition from a clinical-stage biotechnology company toward commercialization as its hematology-oncology portfolio advances into late-stage clinical development. Lead integrated evidence generation strategies spanning registrational support, post-marketing evidence development, real-world evidence, health economics and outcomes research, treatment sequencing, and product differentiation opportunities.
Director, Regulatory Affairs (Global Filing Lead) Revolution MedicinesDirector, Regulatory Affairs (Global Filing Lead)Redwood City, CaliforniaThe 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. 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.
Regulatory Affairs Manager – Heart Failure (on-site) AbbottRegulatory Affairs Manager – Heart Failure (on-site)Pleasanton, California$114,000–$228,000 / yearAs an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Manager, Regulatory Affairs Noctrix HealthManager, Regulatory AffairsPleasanton, California$150,000–$180,000 / yearThe Manager, Regulatory Affairs will work closely with Clinical Affairs, Quality, Engineering, Operations, Marketing, and external regulatory partners to provide regulatory guidance, manage submissions, assess product changes, maintain global registrations, and support post-market regulatory activities. We are seeking an experienced and highly organized Manager, Regulatory Affairs to lead and execute regulatory activities supporting the development, registration, commercialization, and post-market compliance of Noctrix Health’s medical devices.
Director, Government Affairs & Public Policy Harvey, Inc.Director, Government Affairs & Public PolicySan Francisco, CA$260,000–$350,000 / yearA career defined by progressive depth in public policy, government affairs, or regulatory work - whether in-house at a major technology or professional services company, in senior government or regulatory roles, or in a senior advisory capacity at a leading firm. You will develop and cultivate collaborative relationships with policy makers around the world, bringing a candid, well-informed perspective on the future of the legal profession and the policy positions best aligned with fostering and supporting a vibrant, resilient legal ecosystem.
Manager, Regulatory and Market Affairs Pattern Energy Group LPManager, Regulatory and Market AffairsSan Francisco, California$103,000–$138,000 / yearA key function of this role will be to identify, research, analyze, and synthesize the cross section of regulatory and wholesale market rules impacting Pattern’s existing and planned assets in WECC, MISO, ERCOT, SPP, PJM and other priority markets as needed. Importantly, the role will support the coordination with expert consultants and internal SMEs to clearly and regularly identify and lead Pattern’s engagement in regulatory and market design changes, develop Pattern’s positions and execute on strategies to achieve desired objectives.