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.
Senior Regulatory Affairs Specialist - Pleasanton, CA CalyxoSenior Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$145,000–$160,000 / yearMaster's degree with a minimum of 5 years of directly relevant regulatory affairs experience, or Bachelor's degree with a minimum of 8 years of directly relevant regulatory affairs experience, in the medical device, pharmaceutical, biotechnology, or in vitro diagnostics (IVD) industry, including experience with Class II or Class III electromechanical medical devices. As a member of the Calyxo Regulatory Team, you will work closely with Research & Development, Operations, Quality, Clinical and Medical Affairs, Marketing, and Legal to ensure regulatory alignment from concept through commercialization—balancing speed with compliance as we bring category-defining medical devices to market.
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.
Associate Director, Regulatory Affairs CytokineticsAssociate Director, Regulatory AffairsSouth San Francisco, California$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.
Sr Manager/Assoc Director, CMC Regulatory Affairs ErascaSr Manager/Assoc Director, CMC Regulatory AffairsSouth San Francisco, CAAssess 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. 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, Regulatory Affairs Alexza Pharmaceuticals, Inc.Director, Regulatory AffairsFremont, CAManage and prepare post-market filings and product safety reports (e.g., Annual Reports, DSUR, PSUR, REMS Annual Report, Supplements, Technical Documentation File lifecycle maintenance, responses to regulatory information requests). Experience with commercial products, Drug Safety/ Pharmacovigilance (adverse event reporting, DSUR, PSUR, REMS Annual Reports and audits), product approval process, and post-market surveillance.
Director, Regulatory Affairs - Advertising, Promotional And Labeling #4810 GrailDirector, Regulatory Affairs - Advertising, Promotional And Labeling #4810Sunnyvale, CA$189,000–$271,000 / yearThe Director serves as a senior regulatory subject-matter expert and strategic business partner, who leads cross-functional teams in developing promotional materials to ensure compliance with global regulatory markets, while capturing potential regulatory risks. We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine's greatest challenges.
Senior Director, Regulatory Affairs CMC Mirum PharmaceuticalsSenior Director, Regulatory Affairs CMCFoster City, CaliforniaThe Senior Director, Regulatory Affairs CMC is a position requiring a strong leader who will provide strategic and operational leadership, and who will ensure the effectiveness of the Regulatory Affairs CMC team within the Regulatory Affairs department and across the organization. Actively seeks out knowledge of overall corporate planning, business objectives, and current regulatory requirements to develop regulatory positions for assets in Mirum portfolio, and incorporates this knowledge into submission planning.
Staff Regulatory Affairs Engineer Hinge HealthStaff Regulatory Affairs EngineerSan Francisco, CaliforniaThe company has designed its platform to address a broad spectrum of MSK care—from acute injury, to chronic pain, to post-surgical rehabilitation—and the platform can help to ease members’ pain, improve their function, and reduce their need for surgeries, all while driving health equity by allowing members to engage in their exercise therapy sessions from anywhere. You will partner closely with Product, Clinical, and Engineering teams to interpret the evolving FDA framework for AI/ML, helping us navigate complex pathways like Predetermined Change Control Plans (PCCP).
Principal Regulatory Affairs Specialist PROCEPT BioRobotics CorporationPrincipal Regulatory Affairs SpecialistSan Jose, CaliforniaIt 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. Responsible for project timelines and management of regulatory submissions including preparing IDE, 510K and international submissions for new products, new indications, and significant product changes, to ensure compliance with the FDA and international regulations and guidelines.
Staff Regulatory Affairs Specialist (Remote) StrykerStaff Regulatory Affairs Specialist (Remote)Fremont, CaliforniaRemoteHowever, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
Senior Director, Head of Regulatory Affairs Orca BioSenior Director, Head of Regulatory AffairsMenlo Park, CAEssential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the CMO, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements — with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.
Senior Director, Head Of Regulatory Affairs Orca BioSenior Director, Head Of Regulatory AffairsMenlo Park, CA$250,000–$300,000 / yearEssential Duties & Key Responsibilities: Lead Orca Bio's Regulatory Affairs function and serve as the company's senior regulatory leader, working with the CMO, advising executive leadership on strategy, health-authority engagement, lifecycle planning, risks, and emerging requirements - with an immediate focus on post-approval operations, lifecycle management, and preparation for future major submissions. Following Orca Bio's recent commercial approval, the role's immediate focus is heavily weighted toward post-approval regulatory operations and lifecycle management, while also maintaining regulatory readiness for future development programs, new indications, global expansion, CMC Regulatory and other significant milestones as the pipeline evolves.
Senior Program Director, Commercial Regulatory Affairs Compass ConsultingSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAProgram Directors in CORA chair Program Review Committees (PRCs) for their assigned responsibilities, e.g., products within a designated therapeutic area(s) or cross-portfolio activities, such as managed care, interactive marketing, etc. Program Directors lead and manage the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion regulatory review and approval for Roche pharmaceutical products.
NewAssociate, Regulatory Affairs Summit Therapeutics plcAssociate, Regulatory AffairsPalo Alto, CARole and Responsibilities: Provide support of molecule and study-level regulatory activities, including clinical trial application (CTA) and IND submissions, review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary under direction of the Regulatory Affairs Lead. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, clinical studies, coordination of regulatory submission processes and maintenance of submission timelines, regulatory tracking tools, archives, and infrastructure, as assigned.
Senior Program Director, Commercial Regulatory Affairs LancesoftSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CA$129.714 or more years previous experience leading large-scale, cross-functional project teams or other forums in design, development and implementation of policies, programs or projects with significant organizational impact strongly preferred. Senior Program Directors may be assigned responsibilities for leading complex product launches, combination product PRCs, departmental programs, projects or other deliverables with limited direction.
Associate Director, Global Regulatory Affairs Project Management Revolution MedicinesAssociate Director, Global Regulatory Affairs Project ManagementRedwood City, California$186,000–$233,000 / yearDrive the operational planning, coordination, and tracking of new drug marketing application submission activities across cross-functional Filing Teams (including Regulatory, Medical Writing, Nonclinical, Clinical, Safety, Biostatistics, CMC / Pharmaceutical Development and Manufacturing, etc. and external consultants), supporting the Global Filing Lead’s strategic vision. The 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.
Senior Program Director, Commercial Regulatory Affairs Apollo Professional SolutionsSenior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAPreferred Education and Experience: Bachelors degree in Life Sciences, Law, Public Policy, Business, or related field; advanced degrees such as JD, MBA, PharmD, MS, PhD preferred . Join a dynamic and innovative organization at the forefront of global healthcare as our Senior Program Director, Commercial Regulatory Affairs.
Senior Program Director, Commercial Regulatory Affairs SGA Inc.Senior Program Director, Commercial Regulatory AffairsSouth San Francisco, CAResponsibilities : Commercial Regulatory Affairs (CORA) is part that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for the firm's global Pharma Division, which includes all therapeutic areas and all phases of product development from early development to post marketing. Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
Senior Director, Regulatory Affairs Ardelyx, Inc.Senior Director, Regulatory AffairsNewark, CA$259,000–$317,000 / yearPartner with Clinical Development to provide input in designing early stage and registration-enabling trials, advising on endpoints, patient populations, statistical analysis plans, and labeling implications. Qualifications: Bachelor's degree, advanced degree preferred, in life sciences, pharmacy, chemistry, or related field with 12+ years of regulatory affairs experience in the pharmaceutical, biotechnology or medical device industry, or equivalent experience.