NewRegulatory Specialist Sr ActalentRegulatory Specialist SrAlameda, CAJob Description Job Title: Regulatory Specialist Sr Job Description The Regulatory Specialist Sr plays a key role in ensuring timely approval of new medical devices and maintaining continued approval of marketed products. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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.
Associate Director, Regulatory Affairs Advertising and Promotion Mirum PharmaceuticalsAssociate Director, Regulatory Affairs Advertising and PromotionFoster City, California$205,000–$225,000 / yearManage 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). 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.
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.
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).
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.
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.
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.
Associate Director, Global Regulatory Affairs Project Management Revolution Medicines, Inc.Associate Director, Global Regulatory Affairs Project ManagementRedwood City, CA$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.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationSouth San Francisco, CA$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
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.
Executive Director, Regulatory Affairs CMC AllakosExecutive Director, Regulatory Affairs CMCRedwood City, CaliforniaLeads the development of strategic CMC plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, BLAs, CTAs, MAAs, and other relevant regulatory filings. Exec Director Regulatory Affairs/CMC Allakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
Senior Regulatory Affairs Specialist - Pleasanton, CA Calyxo IncSenior Regulatory Affairs Specialist - Pleasanton, CAPleasanton, CA$145,000–$160,000 / yearRequirements: Master'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. In This Role, You Will: Prepare, author, and manage U.S. and international regulatory filings (including 510(k)s, letters to file, registrations/listings, and other regulatory submissions) with appropriate guidance for higher-risk or more complex issues, ensuring timely, high-quality deliverables.
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.
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, California$280,000–$310,000 / yearThe 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.