Collecting information
Organizing data
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.
We are looking to add a full time Quality Assurance Manager to our growing team.. The ideal candidate must have a minimum of 3-5 years of site based Clinical Research experience in phase I-III clinical trials.. The Quality Assurance Manager will be responsible for ensuring research site quality across the research site network.. Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, GCP, standard operating procedures (SOPs) and applicable regulations.. This position is accountable, under the leadership of the VP of Quality Assurance, to develop and lead inspection readiness activities for Clinical Research sites.
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.
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.
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.
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.
We are looking to add a full time Quality Assurance Manager to our growing team. The ideal candidate must have a minimum of 3-5 years of site based Clinical Research experience in phase I-III clinical trials. The Quality Assurance Manager will be responsible for ensuring research site quality across the research site network. Completes clinical investigator site audits to assess adherence to the Study Protocol and associated documents, GCP, standard operating procedures (SOPs) and applicable regulations. This position is accountable, under the leadership of the VP of Quality Assurance, to develop and lead inspection readiness activities for Clinical Research sites.
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.
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 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 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
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.. 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.. Ensure Regulatory Affairs participation on cross-functional project teams supporting new product development and product modifications.. 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.
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.
Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world data and contribute to the advancing of pipeline programs.. Provide mentorship and expertise to educate and develop scientific capabilities of Global Safety Officers and contribute to Benefit-Risk assessment. A proven and successful track record with at least 5-10+ years of experience in biopharmaceutical clinical development in at least one of the following areas: early development, safety, risk management, pharmacoepidemiology or pharmacovigilance.. Experience working in basic science or clinical development, in one or more of the following domains: gene therapy, cell therapy, biologics, small molecules and medical devices.. Knowledgeable of relevant concepts in healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
Whether you're a clinical research associate (CRA), clinical trial coordinator, or involved in regulatory affairs, attending these conferences can significantly enhance your knowledge and skills.. Why Attend : Gain insights into the global regulatory landscape, including updates on the European Union’s Clinical Trials Regulation (CTR).. Key Focus : The summit will focus on clinical trial innovation, precision medicine, and adaptive trial designs.. Clinical Research Coordinator Certification. Clinical Research Associate (CRA) Certification
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office.. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.. On-Site : work five days per week on-site with ad hoc flexibility.
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Vertex is a global biotechnology company that invests in scientific innovation.
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.