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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.
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. Mentor and develop the regulatory, medical writing, and QA teams, fostering a culture of excellence, accountability, and continuous improvement. Manage audits and inspections, ensuring preparedness and compliance with regulatory standards. 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
Bachelor's degree in Pharmacy, Chemistry, Biology, Regulatory Affairs, or a related field required.. PharmD or Master's degree in Regulatory Science, Pharmaceutical Quality, or related discipline strongly preferred.. Minimum 7 years of experience in quality assurance or regulatory compliance within a compounding pharmacy, sterile manufacturing, or pharmaceutical setting.. Lead regulatory reporting, inspections, and responses while proactively staying ahead of industry changes.. Embed a culture of accountability and quality excellence across all departments, reinforcing best practices in pharmacy operations, regulatory compliance, and customer service.
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.
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.
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.
DelRicht is a clinical research company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials.. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved!. Clinical Research Nurse's Main Objective: the Clinical Research Nurse is responsible for providing excellent patient care and a great experience for our patients in a clinical research setting.. Patient visits are completed accurately and efficiently; the Clinical Research Nurse is highly skilled in following written instruction, ensuring that all clinical trial protocols are adhered to 100% of the time. Annual Company Retreat with complimentary travel to New Orleans, Louisiana provided for all full-time team members
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.
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 preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and drug modalities and have led regulatory filings for IND and/or CTA opening studies.. Own the development of asset-specific Regulatory Development Plans, author and manage creation of IND/CTA & Briefing Books, drive pre-IND meetings and other Health Authority-facing interactions related to specific clinical trials.. Advanced degree (M.D., PhD, PharmD, MSc or MPH) with a focus in pharmaceutical sciences, including a minimum of 10 years of pharmaceutical/biotechnology industry experience in Regulatory Affairs lead role with hands-on regulatory experience in all aspects of regulatory affairs.. Prior experience in a combination of metabolic diseases and/or immunology drug development is ideal, and experience in rare diseases is a plus.. Experience with two or more of the following modalities is required: small molecules, biologics, peptides, nucleic acids, or cell therapies; with experience in novel modalities (e.g., gene editing, RNAi, gene therapy) desirable.
Recruitment Consultant specializing in Regulatory Affairs, Validation, and Engineering Role: Director Regulatory Affairs. Degree in life sciences, pharmacy, medicine, or a related field, with at least 12 years of experience in the pharmaceutical/biotech industry, including a minimum of 8 years in Regulatory Affairs with direct strategy and leadership responsibilities.. Job function Industries Biotechnology Research and Pharmaceutical Manufacturing. Associate Director Regulatory Affairs – APAC - Diabetes Care Alameda, CA $146,700.00-$293,300.00 4 weeks ago. Associate Director/ Director, Regulatory Affairs Foster City, CA $170,000.00-$220,000.00 2 weeks ago
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.
Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen.. Manages the reporting and investigation of customer/service complaints, the review of corrective actions and failure investigations, the review of Post Market Surveillance reporting and, if necessary, implements field corrective actions.. Experienced in implementing a complete QMS system to meet US FDA and ISO requirements.. Certifications is a plus: CQE, CQA(BM), CQM, 6 Sigma, ISO Auditor, etc.. Learning & Development Opportunities: On-demand online training and book reimbursement
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
Provide support to assess medical device reporting, field actions, and other post-market surveillance activities.. If you are a relentless problem solver who wants to shape the future of 3D printing, join SprintRay!. Sign in to set job alerts for “Regulatory Affairs Specialist” roles.. Senior Manager Regulatory and Quality Affairs R&D Food Technologist & Regulatory Affairs Specialist Quality Assurance and Compliance Specialist Irvine, CA $80,000.00-$90,000.00 1 week ago. Quality Specialist, Quality Systems and Compliance Regulatory & Cmplnce HC Spec 4 - Cancer Center- Stem Cell Clinc - FT Days Principal Environmental Specialist (Air Quality Compliance) Regulatory & Cmplnce HC Spec 4 - Cancer Center- Stem Cell Clinc - FT Days We’re unlocking community knowledge in a new way.
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.
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
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.
We're hiring a Quality Assurance and Regulatory Affairs Manager. About the Role 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) 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.