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
- Atsena Therapeutics seeks an Associate Director / Director of Regulatory Strategy (Clinical & Nonclinical) to lead global regulatory strategy for gene therapy programs from preclinical to commercialization. You will guide nonclinical and clinical regulatory plans and serve...Regulatory
- ...Companies in Durham, NC is seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing, guiding investigations and driving... ...Manufacturing, Quality, Engineering and Validation to sustain regulatory readiness and robust processes. #J-18808-Ljbffr Novartis...Regulatory
- ...Cell & Gene Therapy Sr. Clinical Project Manager Our FSO team is... ...the accuracy and quality of regulatory data. The Senior Project Manager... ...of Responsibilities Operational delivery. Accountable for... ...potential for repeat business. Lead core project team(s) and...RegulatoryFull timeContract workPart timeWork at officeFlexible hours
$80.6k - $145k
Project Manager I - Cell & Gene Therapy (Sponsor Dedicated) Location:... ...focuses on trial execution, operational oversight, and cross‑functional... ...startup through closeout. Lead or support study start‑up,... ...closely with site monitors, regulatory teams, and contracts personnel...RegulatoryRemote jobWork experience placementWork at officeFlexible hours- ...seeking a Principal Engineer, MS&T to lead upstream gene therapy manufacturing and guide cross‑... ...transfers. This onsite role emphasizes regulatory readiness, investigations, and robust... ...execution across CMOs and internal operations. You will mentor MS&T staff, oversee...Regulatory
- ...Cell and Gene Therapy Nurse Coordinator Work Arrangement: On-Site Location: Durham, NC,... ...coverage for additional therapy types as operational and patient care needs require. This... ...timelines, shipping logistics, regulatory requirements, and treatment scheduling....RegulatoryFull timeFlexible hoursShift workDay shift
- ...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
- ...enable life-changing therapies to reach patients around... ...Director, Technical Operations to join the Durham Leadership... ...and commercial gene therapy programs. Your... ...manufacturing activities. Lead, develop, and empower... ...systems, maintaining regulatory compliance, and...Regulatory
- ...invites a senior leader to direct Technical Operations across Manufacturing, MSAT, and... ...ensuring reliable, compliant delivery of gene therapy programs. Reporting to the Site Head, the Sr Director will shape strategy, lead an expanded operations team, drive safe,...
$93.1k - $232.8k
...) Experience with Cell and Gene Therapy, especially CAR-T therapies. Job Overview Clinical Leads are an integral part of clinical... ...in accordance with Standard Operating Procedures (SOPs), policies... ...projects in compliance with regulatory requirements (International Conference...RegulatoryFull timeContract workPart timeWork at officeLocal areaWorldwide- ## Analytical Lab Operations Specialist IIApplyremote type: Onsitelocations... ...AG, is a fully integrated gene therapy company dedicated to... ...includes Pro10TM, an industry-leading proprietary cell line manufacturing... ...accordance with applicable regulatory requirements and Standard...RegulatoryLocal area
$80.6k - $145k
Project Manager I – Cell & Gene Therapy (Sponsor Dedicated - US Remote... ..., CA) Syneos Health® is a leading fully-integrated life... ...early-phase trial execution, operational oversight, and cross-functional... ...closely with site monitors, regulatory teams, and contracts personnel...RegulatoryFull timeContract workWork experience placementWork at officeRemote workFlexible hours- ...Translational Medicine Project Lead to guide scientific strategies across multiple therapy areas including CNS and Ophthalmology... ...preclinical safety efforts and regulatory documentation while... ...environment aimed at innovative gene therapy solutions. #J-18808-Ljbffr...Regulatory
- Merck is seeking an Operations Manager for our Durham, NC site to lead manufacturing leadership for vaccine and therapeutic production. You will coach a team, drive performance, and ensure regulatory compliance across shifts and audits. The role requires 6+ years in manufacturing...RegulatoryShift work
- Merck in Durham, NC seeks an Operations Manager for Commercial‑Scale Vaccines & Therapeutics. You will lead manufacturing teams across day, evening, and night shifts, coaching... ...manage multiple priorities while maintaining safety and regulatory adherence. #J-18808-Ljbffr MerckRegulatoryNight shiftDay shiftAfternoon shift
- ...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
$145.6k - $270.4k
...accelerate the next generation of gene therapies for patients with serious... ...and leadership, you will lead talented teams, provide technical... ...manufacturing, quality and regulatory functions. ~ Drive... ...authoring laboratory Standard Operating Procedures and technical instructions...RegulatoryLocal areaFlexible hours- The Associate Director / Director, Regulatory Strategy (Clinical & Nonclinical) will lead global regulatory strategy and execution for the company’s gene therapy programs from early research... ...with clinical development, clinical operations, nonclinical, quality and program...Regulatory
- ...Center Operations Manager II Job Category: Donor Center Full-Time On-site Durham... ...the development of life-saving patient therapies utilized by thousands of patients all... ...and external inspections conducted by regulatory agencies and customers Collaborates...RegulatoryFull timeWorldwideShift workWeekend workAfternoon shift
- ...Vice President (VP), GDNF Clinical Development to lead strategic clinical initiatives for gene therapy products. The successful candidate will foster cross... ...development experience. This role supports global regulatory approvals and commercial launches. #J-18808-Ljbffr...Regulatory
- ...wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to... ...includes Pro10(TM), an industry-leading proprietary cell line manufacturing... ...Management, Clinical Operations, Regulatory Affairs, Medical Affairs,...Regulatory
$114.1k - $211.9k
...expansion of Durham campus operations to include Large Molecule drug... ...role will be the Functional Lead for Occupational Safety... ...the Durham campus's overall Gene Therapy/LMO/ADP operations. This role... ...guidance on risk management, regulatory compliance, and transparent...RegulatoryFor contractors$173.6k
...Immuno-Oncology and Cell and Gene Therapy (CAGT) role is at the... ...of science, innovation, and operational execution. As Vice President... ...to patients faster. You will lead cross-functional teams, influence... ...clinical research regulatory requirements i.e., Good Clinical...RegulatoryFull timePart timeImmediate startWork from homeWorldwideFlexible hours$200k - $250k
...experienced Medical Director to lead the medical office engagement... ...development, complying with regulatory requirements, and elevating... ...clinical apheresis and cellular therapies, ensuring our clinical... ...Direct medical strategy and operations for regulated cellular therapies...RegulatoryTemporary workWork at officeLocal areaRemote workRelocation packageFlexible hours- ...enable life-changing therapies to reach patients around... ...optimizing warehouse operations in a cGMP-regulated environment... ...activities Lead investigation and... ...organisation (CDMO) in cell and gene therapy with a mission... ...methods and depth of regulatory expertise. OXB offers...RegulatoryContract work
- ...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...RegulatoryFull timeRemote work
- ...comprehensive pharmaceutical care across the health system. You will supervise dispensing, ensure regulatory compliance, and educate staff and students on medications and therapy optimization. The role requires Doctor of Pharmacy or BS Pharmacy, NC licensure eligibility,...Regulatory
$202.5k - $337.5k
...output of the ViiV Industry Leading Medical Affairs Initiative (VILMA... ...as experts in the HIV therapy/prevention areas and be seen... ...RMD is an HIV specialist, and operates both individually and within... ...Research, Clinical Research, Regulatory Affairs, Training Department,...RegulatoryTemporary work- Remote Jobs is seeking a motivated Project Manager I to support early-phase oncology and gene therapy trials. This role is primarily responsible for ensuring successful execution of CAR-T studies from startup to closeout, coordinating with various stakeholders both remotely...Remote work
- Syneos Health is seeking a Project Manager I for cell and gene therapy trials, ideally located near Los Angeles. The role focuses on trial execution, operational oversight, and coordination. Candidates should have clinical trial experience, particularly in oncology and...Remote job
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