Collecting information
Organizing data
LanceSoft is seeking a travel nurse RN Quality Assurance for a travel nursing job in Novato, California.. Job Description & Requirements Specialty: Quality Assurance Discipline: RN Start Date: 09/15/2025 Duration: 13 weeks 40 hours per week Shift: 8 hours, days Employment Type: Travel Job Profile Summary the Nurse (RN) - Quality and Safety plays a critical role in ensuring that healthcare facilities and providers deliver high-quality patient care.. Their primary responsibility is to monitor the quality of healthcare services provided and support the implementation of quality improvement and patient safety initiatives.. BSN and/or MSN in Nursing preferred License & Certifications: Current valid California RN license BLS Certifications (American Heart Association) are required.. LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness. 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.
The Director will work closely with and report to the Vice President of Regulatory Affairs.. Lead interactions with global Health Authorities, including FDA, EMA, MHRA, PMDA and others, as needed, by developing strategy and briefing documents, preparing for, and leading agency meetings.. Oversee the preparation of and ensure accuracy, completeness, and timeliness of high-quality submissions to US FDA and global health authorities including original and supplemental BLAs, MAAs, INDs, IND amendments, annual reports, special designations (orphan, breakthrough, PRIME, fast track), responses to Health Authority queries, and pediatric study plans.. Collaborate with clinical operations, clinical development, clinical quality assurance, pharmacovigilance team to oversee global clinical trials managed by contract research organizations.. Background investigations are required for all positions by 89bio, consistent with applicable law.
Uses extensive knowledge of US, EU, APAC and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate strategy.. Reviews sections of IND / CTA, BLA / MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.. Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labeling.. Ph. D. and 10+ years of work experience in pharmaceutical regulatory affairs, or B.S / M.S. and 12+ years of work experience in biotech or pharmaceutical regulatory affairs. Preferred candidates will have experience working as a senior leader in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics.
Join to apply for the Associate Director, Regulatory Affairs role at Mirum Pharmaceuticals, Inc.. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients.. The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities for the dedicated regions and related to the development and commercialization of novel liver drugs including quality, preclinical and clinical areas of drug development.. The role is responsible for ensuring full regional regulatory compliance, and overseeing submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA. Experience with regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities).
We are passionate about advancing scientific discoveries to become important medicines for rare disease patients.. The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities related to the development and commercialization of novel drugs including quality, nonclinical and clinical areas of drug development.. The role is responsible for ensuring regulatory compliance and overseeing submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities.. Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.. Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing activities, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you willlead thedevelopmentof labelingfor clinical suppliesas well as development of commercial labeling materialsforOlema products. This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply and CMC teams.. 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical
This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division.. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.. Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care's projects.. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Several Major Biotech companies are seeking Medical Director/Clinical Scientist with drug development experience to join the Oncology program.. The candidate should have an M.D. with board certification/eligibility in hematology/oncology,or a Phd,PharmD with at least 5 years of drug development experience.. Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings. As Medical Monitor, to be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines. Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
Under the general direction of the Vice President for Quality and Patient Safety, the Senior Director for Quality & Patient Safety at Saint Francis (SF) and St. Marys (SM) provides strategic leadership, planning, organization, and management for all aspects of the Quality & Patient Safety programs at these facilities.. Manage hospital epidemiology and infection control activities.. Enhance patient experience in collaboration with UCSF Health Division Director of Experience.. Manage quality and regulatory aspects of outpatient departments, including MACRA/MIPS, CLIA licenses, and other accreditation programs.. Experience with healthcare quality methodologies, data analysis, and hospital management systems.
In collaboration with UCSF Health operational and clinical leadership, and Quality and Safety (Q/S) leadership inclusive of CQO, Vice President, Executive Directors, and Medical Directors of Adult/Pediatric services, the Director participates in setting and implementing the annual strategic priorities for patient safety.. In partnership with operational leaders and key stakeholders, the Director develops strategic and operational plans to build a prospective, proactive, loss prevention, and harm reduction patient safety program that results in improved outcomes.. The Department of Quality & Safety consists of Adult Quality & Safety, Benioff Children's Hospitals (BCH) Quality & Safety, Hospital Epidemiology & Infection Prevention, Regulatory Affairs, Health Equity and Clinical Documentation Integrity.. Strong hospital management experience, with progressive and in-depth expertise in quality, safety and process improvement methodologies, statistical analysis, and database management. Consistently ranked among the top 10 hospitals nationwide by U.S. News & World Report - UCSF Health is committed to providing the most rewarding work experience while delivering the best care available anywhere.
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.. Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU.. Creates and implements CMC regulatory strategies for CTA submissions and marketing applications.. Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans.. BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
Subsense is a pioneering organization specializing in developing innovative nanotechnology solutions aimed at revolutionizing the field of noninvasive daily used Brain-Computer Interfaces and treating Neurodegenerative disease.. We're seeking a visionary Regulatory and Clinical Trials Lead to pioneer our journey in brain-computer interface technology.. Working with a cross functional, interdisciplinary team to integrate hardware, software, nanoscience, data science, and regulatory to build new BCI technology. An advanced degree in biomedical engineering, biotechnology or a related field with 6+ years of relevant experience. Get notified about new Regulatory Specialist jobs in Palo Alto, CA.
Prepare and submit global regulatory applications that support clinical research and marketing approvals in accordance with the companys strategic objectives. Provide strategic guidance and regulatory support for the design and approval of nonclinical studies and clinical trials. Prior experience with European regulations (MDR). Significant experience in leading and preparing major international regulatory submission projects and supportive amendments or supplements, and interfacing with regulatory authorities. Experience in analysis, interpretation and extraction of important concepts from engineering/technical specifications and data, scientific information, international standards and government regulations
Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins.. Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.. About the Opportunity: The Director of Quality Assurance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, lab investigations, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits.. Provide QA leadership and collaborate with Supply Chain, Manufacturing, Quality Control, Analytical Development and Regulatory to ensure that internal operations achieve and maintain compliance with Codexis quality standards.. Technical experience or understanding in fermentation/DSP and quality control.
Pulmonx is looking for a Sr Regulatory Affairs Specialist to join our team supporting all regulatory aspects of our groundbreaking medical devices.. If you enjoy a mix of both tactical and strategic hands-on work with a strong group of Regulatory Affairs experts, please apply!. Location: Remote (or hybrid opportunity in the Bay Area if you prefer!). Stay current with industry trends and best practices in international regulatory affairs.. Minimum of 3-5 years of experience in regulatory affairs, specifically with Class II or Class III medical devices.
Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate. Senior Regulatory Affairs Specialist - Vascular (on-site)Quality Assurance & Regulatory Affairs Manager.. Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave.. Senior Regulatory Affairs Manager – APAC - Diabetes CareSr Regulatory Affairs Specialist - Shockwave Medical.. Senior Regulatory Affairs Specialist – Vascular (on-site)Compliance Manager, Regulatory Change ManagementManager, Regulatory Affairs Advertising and PromotionRegulatory Affairs Manager – Vascular (on-site)
This Regulatory Affairs Manager – APAC position will work on-site at our Alameda, CA location in the Diabetes Care Division.. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.. Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on regulatory requirements in the APAC region for Diabetes care’s projects.. 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Position Title : Regulatory Affairs Manager.. Monitor and analyze state and federal legislation, including California Senate and Assembly bills, that impact Medi-Cal, D-SNP, and delegated healthcare operations. Bachelor's degree in Healthcare Administration, Public Policy, Law, or a related field; OR an equivalent combination of education and progressively responsible experience in healthcare compliance or regulatory affairs. 3+ years of experience in healthcare compliance or regulatory affairs, preferably within a managed care organization, IPA, MSO, TPA, or other delegated entity. Certification required : Certified in Healthcare Compliance (CHC) or Certified in Healthcare Privacy Compliance (CHPC), issued by the Compliance Certification Board (CCB); or ability to obtain certification within 24 months of hire.
The Senior Director, Regulatory Affairs will lead the Global Regulatory Team for an assigned program and work cross-functionally with Clinical Research, Drug Safety, Biometrics, Quality, Medical Affairs, and others to advance the development, approval and lifecycle management of assigned programs.. This position will report to the Executive Director of Regulatory Affairs.. Reviews sections of IND/CTA, NDA/BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. 12+ years of drug development and regulatory affairs experience in the Biotech/ Pharmaceutical industry.. Bachelor of Science in a scientific discipline; advanced degree MD, PharmD, or PhD preferred