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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
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.
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.
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 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.
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.
Additional responsibilities include strategic planning, oversight of IRB submissions and regulatory documentation, compliance with local, federal, and sponsor policies, management of single and multicenter trials, staff education on research policies, budget development and coordination with Research Administration, sponsor relationship management, operational oversight, vendor management, risk mitigation, quality assurance, stakeholder engagement, and data analysis and reporting. The ideal candidate will have a strong background in clinical research implementation with experience and interest in clinical trials, qualitative studies, and survey research; exceptional leadership skills; and a passion for advancing knowledge around food is medicine to improve health. Knowledge and skills as typically acquired through completion of a masters degree in science, businessadministration, public health, healthcare administration, or nursing.. Proven track record of managing multiple clinical trials from start-up to close-out, Experience designing and conducting qualitative research studies.. Proficiency in survey research methods, including data collection and analysis using platforms such as Qualtrics or REDCap
Additional responsibilities include strategic planning, oversight of IRB submissions and regulatory documentation, compliance with local, federal, and sponsor policies, management of single and multicenter trials, staff education on research policies, budget development and coordination with Research Administration, sponsor relationship management, operational oversight, vendor management, risk mitigation, quality assurance, stakeholder engagement, and data analysis and reporting. The ideal candidate will have a strong background in clinical research implementation with experience and interest in clinical trials, qualitative studies, and survey research; exceptional leadership skills; and a passion for advancing knowledge around food is medicine to improve health. Knowledge and skills as typically acquired through completion of a masters degree in science, businessadministration, public health, healthcare administration, or nursing.. Proven track record of managing multiple clinical trials from start-up to close-out, Experience designing and conducting qualitative research studies.. Proficiency in survey research methods, including data collection and analysis using platforms such as Qualtrics or REDCap
The Director will work closely with and report to the Vice President of Regulatory Affairs.. Lead interactions with global Health Authorities, including FDA, EMA, MHRA, PMDA and others, as needed, by developing strategy and briefing documents, preparing for, and leading agency meetings.. Oversee the preparation of and ensure accuracy, completeness, and timeliness of high-quality submissions to US FDA and global health authorities including original and supplemental BLAs, MAAs, INDs, IND amendments, annual reports, special designations (orphan, breakthrough, PRIME, fast track), responses to Health Authority queries, and pediatric study plans.. 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.
The ideal candidate will have experience in biologics drug development, including scientific and tactical regulatory strategy, and late-stage regulatory filings (e.g., NME BLA/NDA, sBLA/sNDA submissions).. Global regulatory leads, head of regulatory operations, tactical implementation team, and lead of Regulatory/Medical Writing will report to this role.. Biotechnology Research and Pharmaceutical Manufacturing. Director, Regulatory Affairs - CMC (Cell Therapy). VICE PRESIDENT, OPERATIONS - Chartwells Higher Education - Washington, DC
Medical Directors of Oncology Clinical Research 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.
As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance you willlead thedevelopmentof labelingfor clinical suppliesas well as development of commercial labeling materialsforOlema products.. This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation.. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research / development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities.. Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply and CMC teams. 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical
The Vice President of Safety and Regulatory Affairs is a senior executive responsible for leading the hospital's enterprise-wide strategies in patient safety and regulatory compliance.. The VP of Safety and Regulatory Affairs also directs development and implementation of a system wide accreditation program to ensure continuous compliance with all federal and state regulatory standards (The Joint Commission, CMS, DPH, MA BORIM).. Serve as the primary liaison with legal counsel on claims, litigation, and potential liability exposure.. Ensure organizational compliance with all regulatory standards related to patient safety and risk, including The Joint Commission (TJC) , Centers for Medicare & Medicaid Services (CMS) , OSHA , and state health departments.. Certified Professional in Healthcare Risk Management (CPHRM), Certified Professional in Patient Safety (CPPS), or related credential.
In partnership with operational leaders and key stakeholders, the Director develops strategic and operational plans to build a prospective, proactive, loss prevention, and harm reduction patient safety program that results in improved outcomes. The Department of Quality & Safety consists of Adult Quality & Safety, Benioff Childrens Hospitals (BCH) Quality & Safety, Hospital Epidemiology & Infection Prevention, Regulatory Affairs, Health Equity and Clinical Documentation Integrity. Strong hospital management experience, with progressive and in-depth expertise in quality, safety and process improvement methodologies, statistical analysis, and database management.. Certified Professional in Healthcare Quality (CPHQ).. Safety Manager (or Director)- Heavy Civil
Senior Biostatistician - Clinical Trials (Remote) Join to apply for the Senior Biostatistician - Clinical Trials (Remote) role at Piper Companies. Join to apply for the Senior Biostatistician - Clinical Trials (Remote) role at Piper Companies. Piper Companies is currently seeking an experienced Biostatistician to join a well-established, global clinical research organization focused on improving the drug development process and access to therapeutics.. Provide statistical consulting as lead biostatistician and communicate between Sponsor and study team. Keywords: Biostatistician, Biostatistics, Principal Biostatistician, Statistician, Statistics, Biostat, Biostats, Clinical Research, Research, Datasets, CRF, Statistical Analysis, Data Analysis, Study Design, Trial Design, SAS, CDISC, ISS, ISE. TLG, TLF, Clinical Trial Data, Data Management, Clinical Trials, Clinical Team, Pharmaceutical, Biopharmaceutical, Pharma, Biopharma, Therapeutics, Biological, Scientific, Health, Dental Vision, Retirement, Benefits, Remote, Senior Biostatistician
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.
The Medical Writer is a writing-based position within our Global Regulatory Affairs department.. Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.. Job function Job function Writing/Editing, Science, and Quality Assurance. Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing. Senior Medical Science Liaison – Dermatology - Upstate NY/NJ New Jersey, United States $150,500.00-$236,500.00 2 weeks ago
San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide.. Under the direction of the Manager, Quality & Regulatory Affairs, the Quality Assurance and Compliance Specialist II participates in maintaining a Quality Management System that supports the manufacture of FDregulated biologic blood, cell and tissue products and other related regulatory activities.. ASQ, CPHQ, Health Care Compliance Certification Board (CHC, CHRC), or similar certification required or must be obtained within two (2) years of hire.. Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory, and clinical research.. Additional Experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred.