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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.
As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.. Bachelors Degree (± 16 years), i n science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience.. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
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.
DESCRIPTION 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.
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
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
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
As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as needed.. Bachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience.. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
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
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.
As an Associate Labeling Specialist, you will work onsite at our global headquarters within our Regulatory Affairs Labeling team. Support and understand related quality subsystems, including non-conformances and corrective/preventative actions (CAPA). At least one year of experience in Regulatory Affairs or Quality Assurance in the medical device industry. Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices, and International Organization for Standardization (ISO) standards. Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
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 organizations 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 Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 CFR. Develop and implement Corrective and Preventive Actions (CAPA) to address nonconformances, trends, and regulatory issues by managing CAPA systems and driving continuous improvements;.. Excellent written and verbal communication skills, including regulatory reporting and documentation;.. Familiarity with quality management and regulatory software (e.g., CAPA systems, regulatory tracking tools);.. 5+ years of experience in quality assurance and regulatory affairs within a regulated industry (medical devices preferred);
The Regulatory Affairs Manager is responsible for leading all necessary Regulatory and Compliance support for the North American corporate office and supporting, where needed, the global business.. Ensure HR operations align with organizational policies and regulatory requirements.. Review and approve US artwork/labeling copy and assist the Global Packaging Team (GPT) in establishing a Global Labelling Specification Manual (GLSM) and ensuring all labeling is consistent with it and also with the Claims Support Dossier (CSD).. 5+ years related regulatory experience with consumer goods in the medical devices, over-the-counter (OTC's), pharmaceuticals, dietary supplements, and/or cosmetics categories.. Strong knowledge of FDA regulations and requirements, monographs/labeling/ claim substantiation across medical devices, over-the-counter (OTC's), pharmaceuticals, dietary supplements, and/or cosmetics categories.
Syndax Pharmaceuticals is looking for a Contractor, GMP Quality Assurance, Commercial.. Support CMC with review of CMO documents including, specifications, methods, labeling, batch records, analytical testing, stability documents, COA/COC for commercial product. Must have experience working in cross-functional teams including, CMC, analytical, supply chain, and regulatory affairs, medical affairs, and commercial. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDapproved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDapproved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment.
Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Regulatory Affairs Manager/Sr Manager. Liaison with other departments within Theradex, including Data Management, Medical Writing Pharmacovigilance, Quality Assurance and Drug Distribution.. Supports clients in preparing for advice meetings with national RAs or the European Medicines Agency.. Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good ClinicalPractice, and regulations and guidelines relating to the conduct of clinical trials
Regulatory Affairs Associate. Handle activities of the Special Investigation Unit (SIU), including reporting and internal investigations.. Juris Doctorate Required. Minimum 3 years of experience in managed care contracting, credentialing, and compliance.. Strong knowledge of MLTC, MAP, Medicaid, and Medicare programs.
The Opportunity As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment.. Assist with activities related to NPI and on market products (510K, PMA, Health Canada submissions and Latin America countries) as neededDetermine and communicate promotional content and approval requirements to cross functional teams.. Required QualificationsBachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experienceMaster's Degree (± 18 years), PreferredMinimum 2 years This position does not require previous regulatory experience.. Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.. Preferred Qualifications Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.
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.