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 2 days ago
Similar jobs that could be interesting for youBased on the Regulatory Operations Lead — Gene Therapy in Durham, NC vacancy
- ...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
- ## 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
- ...re on a mission to enable life-changing therapies to reach patients around the world—and we... ...distribution of clinical and commercial gene and cell therapy products at OXB,... ...Biotech industry to include FDA, EU, JP regulatory requirements as well as ICH/ISO guidelines...RegulatoryRemote work
Oxfordbiom
Durham, NC2 days ago - ...position involves overseeing quality compliance within gene therapy manufacturing and ensuring regulatory adherence. The ideal candidate will have a... ...Assurance. Responsibilities include optimizing systems, leading inspections, and managing quality initiatives to maintain...Regulatory
$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- Women Veterans Interactive is seeking a Manager, Security Operations in Durham, NC. In this full-time role, you will oversee operational... ...will have experience in Security Operations, strong regulatory knowledge, and excellent communication skills. #J-18808-Ljbffr...RegulatoryFull time
$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... ...applicable clinical research regulatory requirements i.e., Good...RegulatoryFull timePart timeImmediate startWorldwideFlexible hours$106.4k - $152k
...mission, Syngenta’s Seeds Field Crops Business Operations and Portfolio Team is seeking a Business Operations Lead in Durham, NC. This role will serve as the connective... ...ERP implementations, governance frameworks, or regulatory/quality environments. MBA or advanced degree....RegulatoryPermanent employmentH1bLocal areaFlexible hoursJobr
Durham, NC1 day ago- ...currently seeking Clinical Quality Operations Manager! This is a full-time... ...Management, Clinical Team leads and with other functions as... ...The CQOMs within a specific therapy area will collectively and periodically... ...for maintaining current regulatory inspection knowledge as it...RegulatoryFull timeContract workWork at officeWorldwide
Fortrea
Durham, NC3 days ago - ...enable life-changing therapies to reach patients around... ...optimizing warehouse operations in a cGMP-regulated environment... ...activities Lead investigation and... ...pioneers in cell and gene therapy, we have more... ...methods, and depth of regulatory expertise. Why Join...Regulatory
OXB
Durham, NC15 hours ago - ...mission to enable life-changing therapies to reach patients around the... ...overseeing all Facilities operations within an FDA-approved clinical... ..., and follow‑up for regulatory inspections, internal audits,... ...original pioneers in cell and gene therapy, we have more than 30...Regulatory
Oxfordbiom
Durham, NC3 days ago - ...mission to enable life-changing therapies to reach patients around the... ...-of-the-art manufacturing operation, playing a key part in advancing... ...would be experience in Gene Therapy operations and training... ...analytical methods, and depth of regulatory expertise. Why Join Us?...RegulatoryWeekend work
Oxford BioMedica
Durham, NC1 day ago - ...Sr. Regulatory Affairs Specialist page is loaded## Sr. Regulatory Affairs Specialistlocations: Durham, NCtime type: Full timeposted on... ...solutions for pain treatment & joint preservation, restorative therapies and bone graft substitutes with products recognized for their...Regulatory
Bioventus
Durham, NC1 day ago - ...Regulatory Affairs Manager page is loaded## Regulatory Affairs Managerlocations: Durham,... ...collaboratively with R&D/Engineering and Operations, Clinical/Medical Affairs, and other... ...treatment & joint preservation, restorative therapies and bone graft substitutes with...Regulatory
Bioventus
Durham, NC1 day ago $119k - $158k
...development and manufacturing organisation (CDMO) in cell and gene therapy with a mission to enable its clients to deliver life changing... ...quality-assurance systems, analytical methods and depth of regulatory expertise. OXB offers a vast number of technologies for viral...RegulatoryFull timeContract work- ...Logistics. As the clinical and advanced therapy part of UPS Healthcare, we reach patients... ...GMP. Writes and revises Standard Operating Procedures as required. Conducts regular... ...Liaises with Health Canada officials during regulatory audits. Provides feedback and assistance...RegulatoryPermanent employmentLocal area
UPS Supply Chain Solutions Inc
Durham, NC4 days ago - ...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
AskBio Asklepios BioPharmaceutical, Inc.
Durham, NC1 day ago - ...to enable life-changing therapies to reach patients around... ...will be responsible for leading warehouse and material operations at the RTP site, ensuring... ...compliance with cGMP, safety, and regulatory requirements. Lead and... ...pioneers in cell and gene therapy, we have more than...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... ..., and reporting to support regulatory submissions (IND, CTA, NDA, briefing...RegulatoryLocal area
$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 contractorsNovartis Group Companies
Durham, NC1 day ago- ...highly organized MDS Coordinator (RN) to lead and oversee the resident assessment process... ...all MDS assessments • Collaborate with therapy, nursing, and interdisciplinary team... ...process • Ensure documentation supports regulatory compliance and optimal reimbursement •...RegulatoryFull timeDay shift
Rose Manor Health and Rehab
Durham, NC5 days ago - ...mission to enable life‑changing therapies to reach patients around the... ...a GMP Biotech/pharmaceutical operation to help evolve our Supply... ...original pioneers in cell and gene therapy, we have more than 30... ...analytical methods, and depth of regulatory expertise. Why Join Us?...RegulatoryContract workWork experience placementLocal area
- ...centered plans of care that incorporate therapeutic exercise, manual therapy, gait and balance training, functional mobility training, and... ...and timely in the electronic health record, adhering to regulatory, payer, and organizational standards. In alignment with PruittHealth...Regulatory
PruittHealth
Durham, NC4 days ago - ...surgical excellence. Our team supports the Operating Room, Emergency Department, Labor &... ...technical skills, equipment, supplies and/or regulatory requirements. Selects, trains and... ...previous leadership experience in a team lead/supervisory or peer leadership capacity....RegulatoryMonday to FridayShift work
Duke Health
Durham, NC8 days ago - A biotechnology company is seeking a Senior Manager/Associate Director of Marketing Operations to oversee the Medical, Legal, and Regulatory review process for promotional content. The ideal candidate should have an Associates Degree and at least 5 years of related experience...RegulatoryRemote job
- ...are seeking a licensed Physical Therapist to provide skilled therapy services to residents in accordance with physician orders and... ...plans Maintain productivity and documentation standards Support regulatory compliance and survey readiness Qualifications Graduate of an...RegulatoryFull timePart timeReliefFlexible hours
Rosemanorrehab
Durham, NC15 hours ago - ...functional goals while ensuring care is delivered safely, accurately, and in compliance with regulatory and reimbursement standards. This position is ideal for a licensed Therapy Assistant who values teamwork, documentation accuracy, and quality resident outcomes....RegulatoryFull timePart timeReliefRelocation packageShift work
Rosemanorrehab
Durham, NC1 day ago - ...Responsible for providing daily oversight of the operations for assigned Sterile Processing units.... ...and operational plans. Actively leads performance improvement, quality, and patient... ...with policies and procedures and all regulatory and accrediting agencies. Duties and...Regulatory
Direct Jobs
Durham, NC1 day ago $125k - $135k
...Overview Project Managers own the operational strategy, determining the... ...will work to develop and lead high performing teams by collaborating... ..., SOPs, client, and regulatory requirements. Partner with... ...working on Cell & Gene Therapy studies Experience working...RegulatoryFull timeContract workPart timeWork at officeLocal areaRemote workFlexible hoursNight shift- ...and accurate documentation in accordance with professional and regulatory standards Record daily treatment charges following approved... ...Supervision Supervise Physical Therapist Assistants, rehab techs, and therapy students Conduct in-service training for staff in restorative...RegulatoryRelocation packageFlexible hours
Camellia Gardens Center for Nursing and Rehabilitation
Durham, NC1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Operations Lead — Gene Therapy. Be the first to apply!
