Regulatory Operations Lead — Gene Therapy
Atsena Therapeutics
A biotechnology company in Durham, NC, is seeking a Regulatory Operations Manager. This role involves overseeing the preparation, submission, and lifecycle management of regulatory filings for gene therapy programs. Ideal candidates have extensive regulatory operations experience, particularly with eCTD submissions, and strong project management skills. The position offers a full-time employment opportunity in a dynamic environment. #J-18808-Ljbffr Atsena Therapeutics
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Regulatory Operations Lead — Gene Therapy in Durham, NC vacancy
- ...Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality...Regulatory
- ...is seeking a Senior Analytical Scientist to lead method development, validation, and lifecycle support for its gene therapy programs. You will manage cross-functional teams... ...of analytical deviations, and regulatory submissions support with a focus on ICH/FDA/...Regulatory
$125.9k - $350.9k
...Customer-Dedicated Delivery Unit, leading complex global oncology... ...development strategy, drive operational excellence, and oversee the... ...programs. Experience in Cell & Gene Therapy (CGT), including CAR-T, gene... ..., data management, safety, regulatory, and other functional areas...RegulatoryFull timePart timeImmediate startWorldwide- Lead the delivery of large, complex global clinical studies and... ...objectives into effective operational strategies and execution plans... ..., data management, safety, regulatory and other functional areas... ...for experience leading Cell & Gene Therapy (CGT), CAR-T, TCR-T, gene...Regulatory
- AskBio Inc. is a gene therapy company focused on analytical sciences, lifecycle management, and regulatory engagement. The role supports cross-functional teams to advance method qualification, validation, and comparability for rAAV programs. You will guide method transfers...Regulatory
- ...Atsena Therapeutics is a clinical-stage gene therapy company that is leveraging novel AAV... ...to reverse or prevent blindness. Our lead program, ATSN-201, is a gene therapy for... ...results. Position Summary The Regulatory Operations Manager will be responsible for overseeing...RegulatoryFull time
- ...Translational Medicine Project Lead will provide scientific guidance for specific therapy areas (CNS, Muscle Metabolism, Renal... ...Brochures, and other regulatory documents. Review and endorse regulatory... ...Experience with AAV, cell & gene therapies drug discovery and development...RegulatoryLocal area
- ...will design and test DNA constructs and serve as technical consultant for CMC activities, regulatory strategies, and process transfer. Based in RTP, NC, you will mentor teammates, lead collaborations with CMDO and QA teams, conduct hands-on experiments, and prepare...Regulatory
- ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...includes Pro10™, an industry‑leading proprietary cell line manufacturing... ...in accordance with applicable regulatory requirements and Standard Operating...RegulatoryLocal area
- GRAIL is seeking a Manager of Biorepository Operations to lead on‑site and off‑site specimen management at our Durham, NC office. The role ensures regulatory compliance, operational excellence, and alignment with company goals, overseeing approximately 1 million samples...RegulatoryWork at office
- GRAIL is hiring a Manager, Biorepository Operations to lead on-site and off-site biorepository activities in a high-capacity environment supporting... ...approximately 1 million samples. This hands-on role ensures regulatory compliance, quality standards, and efficient specimen...Regulatory
- Duke University’s Lemur Center is seeking a Research Manager to lead research operations, regulatory compliance, and team development, partnering with scientists, veterinarians, and staff to advance primate research and welfare. The role emphasizes coordination of projects...Regulatory
- The Operations & Maintenance Specialist II position at Durham County's Triangle Wastewater Treatment Plant is a lead technical role responsible for monitoring, controlling, and maintaining... ...key treatment processes to ensure regulatory compliance, system efficiency, and...RegulatoryRelocation packageRotating shift
- Merck Durham is seeking a Senior Operations Specialist to lead and support the vaccine manufacturing process. The role emphasizes data distillation... ...have hands-on problem-solving ability, experience with regulatory interfaces, and a proactive approach to prioritization in...Regulatory
$106.1k - $295.5k
Job OverviewAssociate Clinical Lead Directors are an integral part of clinical trial... ...requirements in accordance with (Standard Operating Procedures) SOPs, policies and practices... ...of assigned projects in compliance with regulatory requirements (International Conference...RegulatoryFull timeContract workPart timeWork at officeLocal areaImmediate startWorldwide- ...Process Engineer - Cell Therapy MS&T Location: Durham,... ...background in GMP operations, process control strategy... ..., and supporting regulatory compliance in a cross-... ...functional investigations , leading or supporting root... ...experience in a GMP cell/gene therapy environment....RegulatoryContract work
- ...Works Association in Durham, NC seeks an Operations & Maintenance Specialist III to oversee... ...senior-level wastewater plant operations, lead troubleshooting, and mentor junior staff... ...maintenance, process control, and regulatory reporting while ensuring safety and environmental...RegulatoryRotating shift
- ...Site Quality Head for our RTP manufacturing facility. You will establish and lead QA operations ensuring CGMP compliance and robust quality systems across manufacturing, analytics, and regulatory readiness. The role requires 12+ years in QA within pharma/biotech,...Regulatory
- ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...platform includes Pro10, an industry-leading proprietary cell line manufacturing... ...assessment, and support regulatory submissions.The role partners...RegulatoryFull timeWork experience placementLocal area
- ...will establish, maintain, and oversee all Site Quality Operations, ensuring phase-appropriate Quality oversight and CGMP compliance. You will lead a high-performing QA team, drive risk-based decisions, support regulatory inspections, and partner with Manufacturing, Process...Regulatory
- ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...platform includes Pro10, an industry-leading proprietary cell line manufacturing... ...to ensure that assays meet regulatory standards and contribute to the...RegulatoryFull timeWork experience placementLocal area
- ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...platform includes Pro10, an industry-leading proprietary cell line manufacturing... ...scientific expertise, regulatory expectations, and product knowledge...RegulatoryFull timeWork experience placementLocal area
- ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...platform includes Pro10, an industry-leading proprietary cell line manufacturing... ...and author/review CMC regulatory documentsReview and communicate...RegulatoryFull timeWork at officeLocal area
- Description Therapy Smarts is looking for an ABA Program Director... ...will directly oversee clinic operations to ensure efficacy and efficiency... ...other duties as assigned) Lead and manage all aspects of the... ...Inc. Ensure compliance with regulatory requirements, ethical...RegulatoryFull timeTemporary workWork at officeFlexible hours
- ...enable life-changing therapies to reach patients around... ..., summarize and lead validation activities... ...ongoing manufacturing operations, including being on-call... ...pioneers in cell and gene therapy, we have more... ...methods, and depth of regulatory expertise.Why Join Us?...RegulatoryFull timeRemote work
OXB
Durham, NC1 day ago - Humacyte Inc. seeks a Senior Associate, Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role supports strategy, compliance, and submissions for complex manufacturing processes and reports to the Head of Product...RegulatoryRemote job
- ...enable life-changing therapies to reach patients around... ...our GMP manufacturing operations. Working across... ...What You'll Be Doing Lead and Support Automation... ...Ensure systems meet regulatory and compliance requirements... ...pioneers in cell and gene therapy, we offer deep...RegulatoryFor contractorsWorldwide
OXB
Durham, NC16 hours ago - ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...platform includes Pro10, an industry-leading proprietary cell line manufacturing... ...Control (CMC) activities and regulatory strategis, when applicableLead...RegulatoryFull timeWork experience placementWork at officeLocal area
$173.2k - $216.5k
...diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re... ...outreach to all priority leads based on current business strategyStays... ...sound judgment and adheres to relevant regulatory and compliance guidelines and company...RegulatoryFull timeLocal area$126k - $234k
...SummaryDrive the future of gene therapy manufacturing and make a meaningful... ...manufacturing excellence, leading cross-functional... ...scientific investigations, regulatory submissions, and inspectionsLead... ...manufacturing issues across internal operations and external partners (CMOs)...RegulatoryFull timeRelocation package
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Operations Lead — Gene Therapy. Be the first to apply!
Related searches