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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 regulations.. 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 Certification.. 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.
Title : Regulatory Affairs Specialist. The Kardion Regulatory Affairs team is seeking a high energy, driven individual who is looking for the unique opportunity and challenge provided by a clinical stage startup.. The Regulatory Affairs Specialist is a key partner within Regulatory Affairs and will have responsibility of the direct execution of some corporate regulatory filings.. This role will work independently on some submissions and partner with others in the Regulatory Team on other US FDA filings, including IDEs, 510(k)s and PMA. This position requires someone with both a strong execution mindset and ability to explain regulatory processes to the organization.. Experience with complex medical devices, incorporating electro mechanical and disposable components highly desired
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.. 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.. Coordinate the monitoring and assignment of CMC post-approval supplement submission.. Masters in Regulatory Affairs or Science Related field or equivalent.. Minimum 3-5 years in pharmaceutical regulatory affairs or related science academic fields.
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.
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.
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 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.
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 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.
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.
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.
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.
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.
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 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 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, acquiring global product registrations, and updating approved global product registrations for drug substances and drug products. Ensures that global CMC regulatory commitments are defined based on approved submissions for products and communicated to Manufacturing and Quality Assurance. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities).
89bio is seeking an exceptional regulatory professional as Regulatory Affairs Associate Director, to join our team and advance our mission to deliver innovative therapies for treatment of liver and cardiometabolic diseases.. The Associate Director will work closely with and report to the Vice President of Regulatory Affairs.. Collaborate with clinical operations, clinical development, clinical quality assurance, pharmacovigilance team to oversee global clinical trials managed by contract research organizations.. Industries Biotechnology Research and Pharmaceutical Manufacturing. Associate Director/ Director Regulatory Affairs CMC Sr. Director, Regulatory Affairs (CMC Regulatory) South San Francisco, CA $255,000.00-$306,000.00 2 weeks ago
Tanner and Associates is recruiting several Medical Directors of Oncology Clinical Research for major biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey.. Major biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join their Oncology programs.. Candidates should have an M.D. with board certification or eligibility in hematology/oncology, or a PhD, PharmD with at least 5 years of drug development experience.. Develop initial clinical designs for future trials, collaborating with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology teams, and presenting at Therapeutic Development Team meetings.. As Medical Monitor, oversee all aspects of key clinical trials in accordance with ICH/GCP guidelines.
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