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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
Our location in Plano, TX, Austin, TX, Santa Clara, CA, Sylmar CA or Maple Grove, MN currently has an opportunity for a Clinical Evaluation - Senior Project Manager.. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).. Minimum 2 years of experience in regulatory 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), math, engineering, or medical fields.. 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
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 role is part of the RA New Product Introduction (NPI) team, reporting to the Director of Global NPI and U.S. Regulatory Affairs.. 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.. Associate Regulatory Affairs Manager (San Diego) Associate Director of Regulatory Affairs Associate Director of Regulatory Affairs Associate Director, Regulatory Affairs CMC San Diego County, CA $140,000.00-$170,000.00 2 weeks ago. Associate Director, Regulatory Affairs CMC Associate Director Regulatory Affairs CMC Regulatory Affairs Manager - IVD and 510K Manager/ Sr. Manager, Regulatory Affairs Manager, Regulatory Affairs - Hybrid - 134458 Manager, Vendor Contracts & Regulatory Affairs Manager, Regulatory Affairs - Hybrid - 134458 EPMO Project Manager - Work in Regulatory andMedical Affairs domains We’re unlocking community knowledge in a new way.
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. Global Regulatory Affairs Chief of Staff Boston, MA $208,200.00-$327,140.00 2 weeks ago. Associate Director/Director, Regulatory Affairs Senior Director, Global Regulatory Affairs ProFound Therapeutics: Senior Director, IP Counsel Executive Director/Vice President, Regulatory Affairs We’re unlocking community knowledge in a new way.
We are seeking an experienced and highly motivated Director of Regulatory Affairs, Medical Writing, and Quality Assurance to lead our regulatory strategy, medical writing initiatives, and quality assurance processes.. Manage audits and inspections, ensuring preparedness and compliance with regulatory standards.. Bachelors degree in a relevant scientific discipline; advanced degree (e.g., Masters, PhD) preferred.. 5+ years of experience in regulatory affairs, medical writing, and quality assurance within the pharmaceutical or biotechnology industry.. Get notified about new Director of Regulatory Affairs jobs in San Diego, CA.
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. Regulatory Submissions: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.
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.
Further, the Vice President, Regulatory Affairs & Quality Assurance, is responsible for building and mentoring a high-performing team while assuring that ORIC is compliant with federal and state legislation, health authority regulations and guidances, and driving a culture of quality and accountability across the organization.. Provide oversight for global regulatory affairs in all major regions (North America, Europe, Asia Pacific, Latin America) for all regulatory functions, including Clinical, Non-clinical, Regulatory Operations, and broad oversight for Regulatory CMC and Regulatory Diagnostics. Ensure highquality and timely regulatory submissions (IND/CTA/NDA/MAA/PMA) in compliance with all applicable regulatory requirements, and in alignment with corporate goals. Demonstrated success leading major regulatory submissions (NDA/BLA/MAA) through approval. Strong experience with GXP compliance and building quality systems (QMS) in a development-stage and/or commercial environment
The VP will also lead Medical Affairs activities including clinical studies, Customer Contact Center, and pharmacovigilance.. Product categories include OTC monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements, and EPregistered products.. The VP, Quality Assurance and Regulatory Affairs will foster close cooperative relationships with all functions in the company relative to compliance, working with Marketing, Product Development, Package Development, Legal, and Operations to execute all product and labeling claims and strategies for the company's brands.. The VP will lead and apply Quality Assurance and cGMP expertise for OTC drug products (monographed and NDA/ANDA), medical devices, dietary supplements, and cosmetics.. The VP will provide clear direction to Medical Affairs on clinical studies, the Customer Contact Center, and pharmacovigilance.
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
Our location in Plano, TX, Austin, TX, Santa Clara, CA, Sylmar CA or Maple Grove, MN currently has an opportunity for a Clinical Evaluation - Senior Project Manager.. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers).. Minimum 2 years of experience in regulatory 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), math, engineering, or medical fields.. 5-7+ years of experience in clinical research, clinical affairs, regulatory affairs, or quality systems, in the medical device or pharmaceuticals industry.
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness. Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
We're hiring a Quality Assurance and Regulatory Affairs Manager. We 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).. 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.
State Regulatory Affairs Specialist, Medicaid and Health Policy. Join to apply for the State Regulatory Affairs Specialist, Medicaid and Health Policy role at National Organization for Rare Disorders. Familiarity with state Medicaid waiver programs and managed care regulations a plus.. This position is fully remote with required travel for special events, conferences and meetings.. Regulatory Affairs Innovation Lead - VIE ContractRegulatory Affairs CMC Expert - BiologicsCompliance Associate, Financial Regulatory Affairs
Subsense is a pioneering organization specializing in developing innovative nanotechnology solutions aimed at revolutionizing the field of noninvasive daily used Brain-Computer Interfaces and treating Neurodegenerative disease.. We're seeking a visionary Regulatory and Clinical Trials Lead to pioneer our journey in brain-computer interface technology.. Working with a cross functional, interdisciplinary team to integrate hardware, software, nanoscience, data science, and regulatory to build new BCI technology. An advanced degree in biomedical engineering, biotechnology or a related field with 6+ years of relevant experience. Get notified about new Regulatory Specialist jobs in Palo Alto, CA.
The VP will also lead Medical Affairs activities including clinical studies, Customer Contact Center, and pharmacovigilance.. Product categories include OTC monograph drugs, OTC NDAs, Medical Devices, Cosmetics, Dietary Supplements, and EPregistered products.. The VP, Quality Assurance and Regulatory Affairs will foster close cooperative relationships with all functions in the company relative to compliance, working with Marketing, Product Development, Package Development, Legal, and Operations to execute all product and labeling claims and strategies for the companys brands.. The VP will lead and apply Quality Assurance and cGMP expertise for OTC drug products (monographed and NDA/ANDA), medical devices, dietary supplements, and cosmetics.. The VP will provide clear direction to Medical Affairs on clinical studies, the Customer Contact Center, and pharmacovigilance.
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.
Title: Clinical Research Nephrologist. We are seeking a Board-Certified Physician to join as a Clinical Research Physician supporting Phase I-IV clinical trials in Chicago, IL. In this role, you will ensure protocol compliance, patient safety, and collaborate with sponsors, CROs, and research teams to advance multi-therapeutic studies.. Serve as Principal Investigator (PI) or Sub-Investigator (Sub-I) for clinical trials.. Record patient interactions, manage adverse events (AEs/SAEs), and maintain compliance with EHR/EDC systems.. Proficiency in EHR systems, medical documentation, and clinical trial platforms (EDC, CTMS).
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