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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 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.
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.
Jiangsu Hengrui Pharmaceuticals Co., Ltd. ("Hengrui") is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products.. This is a full-time (Monday to Friday) exempt salaried position on site at Princeton NJ office.. Review, evaluate, compile, publish and submit regulatory submissions such as Initial ANDA, Initial IND, Initial DMF, CMC supplements, Amendments, Annual Reports, etc., using publishing software like Omnicia, Lorenz (docubridge), Veeva, etc.. Masters in Regulatory Affairs or Science Related field or equivalent.. Minimum 3-5 years in pharmaceutical regulatory affairs or related science academic fields.
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.
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're hiring a Quality Assurance and Regulatory Affairs Manager DENTALEZ is a dental equipment manufacturing company committed to providing state-of-the-art dental practice solutions for unlimited interconnectivity, choice, and control.. About the RoleWe are seeking a Quality and Regulatory Affairs Manager (QA/RA Manager) to lead our quality assurance and regulatory compliance efforts.. ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) preferred.. Manage RMA, QC Inspection, document control, acceptance activities, calibration, QMS training, and quality engineering functions.. Oversee post-market surveillance, adverse event reporting, internal and external audits.
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.
Title: Regulatory Affairs Associate. Reporting to: Regulatory Affairs Manager. We are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed.. Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 10 direct markets.. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft and the ARTAS iX Robotic Hair Restoration system.
Description Non-profit healthcare company is hiring a Regulatory Affairs Associate Attorney to join its Bronx County, New York team.. 3+ years of experience in a legal environment for a managed long term care facility. Knowledge of Medicaid & Medicare programs. Salary: $150K - $180K commensurate with experience + benefits including healthcare, dental, vision, life insurance, long-term disability, 401K, PTO & more. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship, religion, creed, gender, gender identity, sex, sexual orientation, marital status, age, disability, medical condition, height, weight, military status or any other characteristic protected by federal, state, or local law.
Overview Verathon is looking for a Director, Regulatory Affairs to become the newest member of our QA/RA Team located in Bothell, WA. This is an onsite position based in our Bothell WA Headquarters.. The Director, Regulatory Affairs is responsible for managing regulatory strategies for worldwide device and registration of Verathon products, in accordance with product development and business objectives.. Lead, mentor, and develop a team of Regulatory Affairs professionals and contracted clinical study, medical professionals, and other consultants. 8+ years experience in regulatory affairs within a regulated industry (.. , medical devices, pharmaceuticals, biotechnology, or healthcare products)
Our program gives fellows an opportunity to work with our innovative biopharmaceutical industry partners while collaborating with Northeastern University faculty in professional and career development, service, scholarship, and teaching.. In partnership with Northeastern University, Ironwood Pharmaceuticals is offering a two-yearGlobal Patient Safety and Regulatory Affairs PharmD fellowship based in Boston.. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure (SBS-IF), as well as several earlier stage assets.. During the second year of the fellowship, the fellow will work within regulatory affairs to gain experience in global/regional labeling, maintenance of IND and/or NDA applications, regulatory strategy, regulatory intelligence, Agency meeting management and correspondence, and regulatory operations.. In both functions, the fellow will have the opportunity to work collaboratively with other functional areas within Ironwood including clinical development, medical scientific affairs, program management, data sciences, quality and compliance, nonclinical, medical writing and publications, and chemistry, manufacturing, and controls as well as experience partner interactions and engage in vendor oversight.
Nurse – LPN or RN – Clinical Trials and Drug Development 8938. schedule Job is at a clinical research facility Preparing for upcoming studies, service healthy population of patients during clinical trial studies, dosing, watching for side effects to trials, administering trial doses, reporting and investigating side effects.. 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
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.
Quality Assurance and Regulatory Affairs Manager. Quality and Regulatory Affairs Manager. ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) preferred.. Manage RMA, QC Inspection, document control, acceptance activities, calibration, QMS training, and quality engineering functions.. Oversee post-market surveillance, adverse event reporting, internal and external audits.
We are recruiting for experienced Regulatory Affairs Professionals on various levels.. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus.. Regulatory submission of Clinical Trial in Spain according to EU-CT directive but also via EU-CTR process (experience in this field would be appreciated).. Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.. Relevant clinical research experience in regulatory affairs and management of international clinical trials
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 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.. schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI).. 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.