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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.
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.
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.
We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA / QA) experienced professional to join DermBiont.. Knowledge of GLP and GCP, Pharmacovigilance (PV), ICH, FDA requirements and guidelines for small molecules, including drafting, interpreting, and implementing quality assurance policies and procedures for regulatory documents, as well as establishing document management activities.. Ability to assess R&D, non-clinical, and clinical documents for compliance to regulatory standards for GLP or GCP and to identify areas of non-compliance.. Provide knowledge of GLP and GCP, US Food and Drug Administration (FDA), International Council for Harmonization (ICH), Global Pharmacovigilance (GPV), regulations, guidelines, and industry standards.. Define and manage phase appropriate QA activities in support of preclinical studies and clinical trials.
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
Xenon Pharmaceuticals ( NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders.. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. Build effective partnerships with cross-functional teams (e.g., regulatory affairs, clinical development, biometrics).. Extensive experience writing regulatory submission documents across all phases of drug development (e.g., clinical protocols, Investigator’s Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs).. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
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.
Uses extensive knowledge of US, EU, APAC and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate strategy. Reviews sections of IND / CTA, BLA / MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labeling. Ph. D. and 10+ years of work experience in pharmaceutical regulatory affairs, or B.S / M.S. and 12+ years of work experience in biotech or pharmaceutical regulatory affairs.. Preferred candidates will have experience working as a senior leader in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics.
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.
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 the largest consumer-directed home care agency in NY State, and are continually expanding our areas of focus including operations in other states and tech-based innovations. This role will have a deep understanding of healthcare regulatory frameworks and risk management, the Director of Regulatory Affairs & Compliance will ensure FreedomCare’s policies, procedures, and operations comply with laws and regulations. Regulatory Compliance Management: Manage operational plans to ensure compliance with CMS, OMIG, state DOH departments, HIPPA, TCPA, anti-kickback statues, False Claims Act, Stark Law and other relevant regulations.. Cross-functional collaboration: Collaborate with internal teams such as Legal, Operations, Marketing, National Expansion, Technology, Clinical, Physician Practice, People & Culture, and others to ensure cohesive compliance efforts.. Industry Expertise: Maintain up-to-date knowledge of laws and regulations impacting Medicaid and home care Ideal Candidate Will Possess: Bachelor’s degree in healthcare administration, business or a related field.
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.
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.
BostonGene is redefining precision medicine with its AI-powered, multiomic approach to understanding and treating complex diseases.. By integrating deep molecular profiling—including genomics, proteomics and the immune system—the platform delivers a systems biology view that accelerates drug development and clinical decision-making.. Oversee the maintenance and continuous improvement of the QMS, including internal audits, corrective and preventive actions (CAPA), and change control management within both GCLP and CLIA frameworks.. FDA and PMDA Device Regulations: Comprehensive knowledge and experience with FDA and PMDA device regulations, including pre-market submissions, post-market surveillance, and quality system requirements for medical devices.. Background in oncology, molecular diagnostics, or bioinformatics-based services with specific knowledge of AI/ML applications.
The Director of Quality & Regulatory Affairs will be responsible for operational, tactical and strategic global initiatives in support of successful commercial product approvals, market introductions and post-marketing activities.. The Director will also provide oversight for clinical research.. Experience preparing and defending IND, HDE, PMA and 510K submissions is mandatory.. REQUIRED KNOWLEDGE: Knowledge of Quality & Regulatory Affairs documentation and design and implementation, demonstrated leadership skills, strong communication skills both written and spoken. EXPERIENCE: Extensive experience preparing regulatory submittals IND, HDE, PMA and 510K, creating and revising SOPs, FDA & ISO Audit experience
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
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.
QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration.. Antibody Drug Conjugates (ADC), Clinical Pharmacology, Data Modeling, Data Modeling Software, Data Modeling Tools, Data Visualization, Drug Development, Pharmacology Research, Pharmacometrics, Regulatory Documents. C (Programming Language), Clinical Trials, MathWorks SimBiology, MATLAB, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Oncology, Pharmaceutical Development, PKPD Modeling, Programming Languages, Regulatory Submissions, R Programming, T Cells