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The Director of Clinical Pharmacology & Pharmacometrics will lead the strategic and operational aspects of clinical pharmacology and pharmacometric activities across the drug development lifecycle.. This individual will play a critical role in optimizing dose selection, trial design, and regulatory strategy through the application of quantitative pharmacology and model-informed drug development (MIDD) principles.. Lead the design, execution, and interpretation of clinical pharmacology studies (e.g., ADME, PK/PD, drug-drug interaction, special populations).. Collaborate cross-functionally with clinical development, regulatory affairs, biostatistics, and nonclinical teams to support program goals.. PhD, PharmD, or MD in Clinical Pharmacology, Pharmaceutical Sciences, or a related discipline.
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 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.
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.
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options.. The Associate Director will work closely with and report to the Vice President of Regulatory Affairs.. Lead preparation of and ensuring accuracy, completeness, and timeliness of high-quality submissions to US FDA including INDs, IND amendments, annual reports, special designations (orphan, breakthrough, fast track), responses to Health Authority queries.. 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.
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.
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 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
Anteris is a science-driven structural heart company that is redefining expectations and advancing the field through cutting-edge solutions focused on restoring native-like physiology versus treating symptoms of structural heart disease.. Reporting to the SVP of Clinical and Regulatory, the Director of Regulatory Affairs will support the strategic direction and lead the day-to-day execution of global regulatory activities.. This role will be responsible for preparing high-quality regulatory submissions, supporting interactions with the FDA and other international regulatory bodies, and ensuring compliance with global requirements related to market authorizations, post-market surveillance, and regulatory reporting.. Author, review, and approve internal procedures related to regulatory affairs operations and compliance.. Hands-on leadership of regulatory submissions for Class III/PMA devices, including FDA (IDE, PMA) and EU (MDR, CA, CE Mark) pathways.
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 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.
The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements.. Track regulatory changes affecting compounding, controlled substances, and labeling requirements. Associate degree in Life Sciences, Regulatory Affairs, or related field (Bachelor's preferred). Experience in sterile or non-sterile compounding (503A or 503B environments). Regulatory Affairs Certification (RAC) or DEA compliance training (preferred)
Under the direction of Principal Investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials. Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR. Certified Clinical Research Coordinator (CCRC) or certification eligible, Certified Clinical Research Professional (CCRP). Experience applying knowledge of regulations governing clinical research (CFR, GCP, HIPAA). Demonstrated understanding of statutes and guidelines relevant to regulatory affairs in clinical research.
SUMMARY: Plans, coordinates, monitors compliance with federal, state and local regulations; manages accreditation activities necessary for maintaining required accreditation; manages requirements for certifications and licensure from various organizations, such as Joint Commission (JC), California Department of Public Health (CDPH), CMS, OSHPD, CDPH Lab Field Services, CDPH Radiologic Health Branch, etc.. Actively coordinates the organization's readiness rounds program and is primarily responsible for the development, communication, implementation and tracking of action plans necessary to close identified gaps in care or compliance with The Joint - Commission (TJC) standards and Centers for Medicare and Medicaid Services (CMS) and Title 22.. Manages onsite accreditation and regulatory surveys; supports command center activities.. Preferred Licenses/Certifications: Certified as a Professional Healthcare Quality (CPHQ) or Certified as a Joint Commission Professional (CJCP); LEAN/Six Sigma Education: Bachelor's degree in nursing or healthcare related field.. Required Experience: Five years of hospital operations or patient care experience; two years in accreditation/licensing/regulatory compliance/ quality/performance improvement/patient safety in healthcare; experience applying quality assurance/performance improvement (QAPI) and customer service approaches; experience with Midas, Epic / Electronic Health Record (EHR), County Health Systems, OSHPD.
This is a contract job opportunity.. This would be the perfect fit for those looking to transition from hospital settings into nursing lab settings.. Working with only healthy population of candidates during medical dosing trials.. Must be proficient with computers and electronic charting as Nurses are required to document trial doses and effects into computer systems
LaSalle Network has partnered with a healthcare provider in Beverly Hills, TX, in their search for a Medical Billing Specialist to join their team.. As a Medical Billing Specialist , you will play a vital role in our client’s revenue cycle management by ensuring the timely and accurate processing of medical claims and invoices.. Review patient encounters and documentation to accurately assign ICD-10, CPT and HCPCS codes for billing purposes. Follow up on outstanding claims and denials, researching and resolving billing discrepancies and appeals in a timely manner. Proficiency in medical coding systems, including ICD-10, CPT and HCPCS
The position provides Quality Assurance support for the Translational Medicine, Clinical Development, and Clinical Operations functions, including the areas of clinical pharmacology, toxicology, pharmacovigilance, clinical trial conduct, and clinical data management.. The Director, Clinical Quality Assurance works directly with the Cardurion Quality Team, Translational Medicine, Cardurion K.K., Clinical Development, Clinical Operations, Regulatory Affairs, and the corresponding quality assurance staff members from the various CROs, clinical study sites, and clinical service providers to ensure effective execution of the Cardurion Quality System requirements and compliance with the applicable GLP, GCP, and GPvP guidelines, regulations, and industry standards.. Provides Quality Assurance input/guidance on the handling of GLP and GCP non-compliance events to ensure these events are appropriately reported, investigated, and documented and that appropriate CAPA are identified and implemented.. Remains current in the US and international regulatory and industry requirements and inspectional trends for GLP, GCP, GPvP, and pharmaceutical quality systems.. Highly competitive benefits package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
The Director of Regulatory Affairs is responsible for overseeing regulatory compliance initiatives to support patient safety and quality, ensuring adherence to Federal, State, and local regulations.. This role focuses on managing accreditation and certification processes, including standards from The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), and State/Local Departments of Health, in consultation with legal counsel as needed.. 8-10 years of healthcare experience with knowledge of accreditation/certification processes and performance improvement methods.. Experience in regulatory compliance, quality improvement, patient safety, risk management, or project management preferred.. Certified Professional in Healthcare Quality (CPHQ) preferred.
The Senior Director of Global Regulatory Affairs – CMC (GRCMC) leads and manages the scientific and regulatory efforts of the team, overseeing CMC regulatory activities for global submissions and interactions with regulatory authorities for Lilly’s synthetic molecule portfolio. Recognized as a deep scientific technical expert in CMC drug development and/or pharmaceutical manufacturing technology and processes. Ensures department has broad technical knowledge and expertise in global CMC regulatory requirements and guidelines for conducting clinical trials, obtaining global product registrations, and updating approved global product registrations for drug substances and drug products. Provides regulatory sciences leadership, decision making, guidance and coaching for CMC regulatory scientists. Ensures that global CMC regulatory commitments are defined based on approved submissions for products and communicated to Manufacturing and Quality Assurance.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. As a Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional stakeholders in compliance with the appropriate regulations. Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment.