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Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products.. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
Further, the Vice President, Regulatory Affairs & Quality Assurance, is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation, health authority regulations and guidances, and driving a culture of quality and accountability across the organization.. Provide oversight for global regulatory affairs in all major regions (North America, Europe, Asia Pacific, Latin America) for all regulatory functions, including Clinical, Non-clinical, Regulatory Operations, and broad oversight for Regulatory CMC and Regulatory Diagnostics. Ensure high-quality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements, and in alignment with corporate goals. Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval. Strong experience with GXP compliance and building quality systems (QMS) in a development-stage and/or commercial environment
We are seeking an experienced and highly motivated Director of Regulatory Affairs, Medical Writing, and Quality Assurance to lead our regulatory strategy, medical writing initiatives, and quality assurance processes.. Mentor and develop the regulatory, medical writing, and QA teams, fostering a culture of excellence, accountability, and continuous improvement.. Manage audits and inspections, ensuring preparedness and compliance with regulatory standards.. 5+ years of experience in regulatory affairs, medical writing, and quality assurance within the pharmaceutical or biotechnology industry.. Get notified about new Director of Regulatory Affairs jobs in San Diego, CA
Regulatory Affairs Manager - Bilingual (Mandarin & English)Regulatory Affairs Manager - Bilingual (Mandarin & English). Get notified about new Regulatory Affairs Manager jobs in San Diego, CA. Associate Regulatory Affairs Manager (San Diego). Senior Regulatory Affairs Manager (Onsite)Regulatory Affairs Associate Director or Senior Manager. Staff Regulatory Affairs Specialist - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid) - Becton DickinsonStaff Regulatory Affairs Specialist (Hybrid)
This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs.. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Associate Regulatory Affairs Manager (San Diego) Associate Director of Regulatory Affairs Associate Director of Regulatory Affairs Associate Director, Regulatory Affairs CMC San Diego County, CA $140,000.00-$170,000.00 2 weeks ago. Associate Director, Regulatory Affairs CMC Associate Director Regulatory Affairs CMC Regulatory Affairs Manager - IVD and 510K Manager/ Sr. Manager, Regulatory Affairs Manager, Regulatory Affairs - Hybrid - 134458 Manager, Vendor Contracts & Regulatory Affairs Manager, Regulatory Affairs - Hybrid - 134458 EPMO Project Manager - Work in Regulatory andMedical Affairs domains We’re unlocking community knowledge in a new way.
Coordinates global CMC regulatory activities necessary to conduct clinical trials, achieve marketing approval of drug candidates and ultimately support the life-cycle of approved products.. Supports CMC regulatory affairs activities for marketed products and compounds in development in line with US and ex-US regulatory requirements.. Supports the regulatory function on development teams providing CMC regulatory guidance and strategy including identifying and assessing/mitigating regulatory risks.. Targeting at least 8 years of progressively responsible experience in CMC Regulatory Affairs with a focus on small molecule drug development.. Previous experience in the preparation and submission of the CMC components of IND/CTA and NDA and ex-US MAA submissions.
The Moores Cancer Center (MCC) is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County.. The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.. Reporting directly to the Executive Administrative Director (EAD) of the Moores Cancer Center Clinical Trials Office (CTO), the Manager, Regulatory Affairs leads a team of Regulatory Coordinators while taking on more programmatic responsibilities.. Acting as a crucial link between the MCC CTO and various stakeholders, the Regulatory Manager serves as a liaison with both the Institutional Review Board (local and commercial) and ancillary committees.. Lead the CTO Regulatory Affairs unit to support compliant study activation and management of active clinical trials managed by the CTO. Apply extensive knowledge of clinical research protocols and processes to design research projects of large scope and high degrees of complexity.
This position, Associate Director Regulatory Affairs , works out of our San Diego, CA location in the Infectious Diseases Division.. This role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs.. Approve regulatory filing strategies based on proposed preclinical, clinical, and manufacturing changes.. Bachelor's degree, preferably in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.. 7+ years' experience in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
The Director will work cross-functionally with R&D, Systems Engineering, IT-Cybersecurity, Human Factors, Regulatory Affairs, and other internal and external stakeholders to ensure seamless integration of digital products into broader system architectures.. Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.. 10+ years in software design quality assurance within the medical device or medical digital health industry.. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process.. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller.
Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials.. Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for the following, under the direction of Department Leadership.. The Regulatory Affairs Manager will oversee, and assist in the review of promotional materials to comply with regional regulatory requirements concerning advertising and promotion.. The Regulatory Affairs Manager will champion continuous improvement efforts and lead department initiatives.. Bachelor's degree in bioengineering/biomedical engineering,biochemistry, chemistry, molecular biology, or related technical science discipline required.
With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.. This position may be fully remote; however, preference will be given to San Diego-based applicants.. Working with the Executive Director, Regulatory and Medical Writing, collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents [Module 2], etc. Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents.. Rare disease experience is a plus.
The USC Keck School of Medicine - Alzheimer Therapeutic Research Institute (ATRI), located in San Diego, California, is an academic institute comprised of an expert panel of scientific collaborators, committed to advancing the development of new treatments for Alzheimer’s Disease (AD) through innovative clinical trials.. Collaborate with the Project Director and other functional groups in the planning and administration of all phases of multi-site clinical trials. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety.. Bachelor's degree in Biological Science or related field(s).. Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC).
All recruiting and talent agency decisions are strictly managed by the internal IDEAYA Human Resources function.. IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.. The Director of GCP QA is a leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP).. The candidate will represent QA and function as the GCP QA lead and accountable for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP) oversight for all Ideaya Bio. clinical studies.
Company: (Confidential Biotech Company). Position Overview: The company is seeking a highly motivated and experienced Director or Senior Director of Analytical Development to join their team.. This is a unique opportunity to lead analytical development efforts, particularly focusing on adeno-associated virus (AAV) vectors, and make a significant impact on their mission to transform heart disease treatment.. Impact at Every Stage: You'll lead regulatory CMC strategy for investigational and marketed products, influencing everything from INDs to global marketing applications.. Develop and implement global CMC regulatory strategies across the product portfolio
Looking for an experienced Regulatory & Quality Assurance Supervisor to help us maintain compliance and drive excellence in our QMS. This role is perfect for someone who thrives in dynamic environments and wants to make a direct impact on patient safety and product quality.. Serve as a key point of contact during FDA, ISO, and international audits. Manage and improve the Quality Management System (QMS), including internal audits, change control, and risk management. 5+ years of Regulatory Affairs and Quality Assurance experience in medical devices (preferably Spinal or Orthopedic experience). Regulatory Affairs Certification (RAC) preferred
Quivvy Tech is expanding its team and is seeking dedicated telemedicine physicians to join us!. As the fastest growing national telemedicine network in the U.S., we focus on delivering high-quality healthcare through our advanced platform.. Our triage call center pre-screens all patients for medical necessity while ensuring compliance with legal and regulatory standards, all while prioritizing a positive patient experience.. Must be a provider for commercial insurance and/or Medicare.. If you are interested in joining our innovative team and making a difference in telemedicine, please reach out for more information!
About Synchron Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world.. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world.. Develop and execute calibration procedures for production and test equipment to ensure measurement accuracy and compliance with quality standards; maintain detailed records of calibration activities.. In addition to base pay, this role may be eligible for discretionary bonuses and/or equity grants subject to board approval and company policy.. Discretionary unlimited PTO
The USC Keck School of Medicine - Alzheimer’s Therapeutic Research Institute (ATRI), located in San Diego, California is an academic institute comprised of scientific collaborators committed to advancing the development of new treatments for Alzheimer’s disease through innovative clinical trials. USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Minimum Education: Bachelor's degree In Biological Science Or in related field(s) Addtional Education Requirements Combined experience/education as substitute for minimum education Minimum Experience: 2 years in on-site clinical trial monitoring. Preferred Education: Bachelor's degree And Master's degree In Neurosciences Or Public Health Or Pharmacology Or in related field(s) Preferred Certifications: Certified Clinical Research Associate (CCRA) and/or Certified Clinical Research Coordinator (CCRC). Strong understanding of current GCP guidelines applicable to the clinical research conduct.
The company was co-founded in 2022 by Drs. Athena Countouriotis and Mohammad Hirmand (former CEO and CMO of Turning Point Therapeutics, respectively).. Reporting to the Senior Vice President, Regulatory Affairs, the Senior Manager/Associate Director, Medical Writing will author, edit and provide input to documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment.. Thorough knowledge of clinical research concepts, practices, and Food and Drug Administration (FDA)/European Medicines Agency (EMA)regulations and International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH)/Good Clinical Practices (GCPs) Guidelines regarding drug development phases, clinical research, and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing. A reasonable estimate of the base salary range for this role is $170,000-$179,000 for a Senior Manager and $179,000 – $187,000 for an Associate Director.. Medical Science Liaison, Wound Care, San Diego.
MedInsight is a subsidiary of Milliman; a global, employee-owned consultancy providing actuarial consulting, retirement funding and healthcare financing, enterprise risk management and regulatory compliance, data analytics and business transformation as well as a range of other consulting and technology solutions.. As the Director, Government Programs - Medicare & Medicaid, you will lead the strategic expansion of MedInsight's footprint in the Medicare Advantage and Medicaid Managed Care sectors.. Serve as a thought leader on value-based care contracting, continuously assessing the evolving needs of government payers and adapting strategy accordingly.. Familiarity with Medicaid waiver programs, dual-eligible strategies, and state innovation models. Background in government affairs, regulatory strategy, or public health policy a plus