Regulatory Lead, Clinical Trials - Gene Therapy (Hybrid)
University of Pennsylvania
The University of Pennsylvania’s Neurogenetics Therapy Center seeks a Clinical Research Regulatory Specialist B to coordinate trial startup activities, maintain regulatory documents, and support ongoing regulatory activities in line with ICH-GCP and institutional standards. You will work with investigators, sponsors, CROs and study teams to track submissions, prepare regulatory documentation, and ensure inspection-ready files throughout the trial lifecycle in a fast-paced, collaborative #J-18808-Ljbffr University of Pennsylvania
- ...Medical Director specializing in Movement Disorders to lead clinical strategy for gene therapy programs. This role requires expertise in clinical trials and collaboration across teams to ensure patient safety and regulatory compliance. With over 6 years in relevant clinical...Regulatory
- AskBio Inc. in the United States offers a secondment opportunity for a Director of Regulatory Affairs, serving as the U.S.-based regulatory strategy lead for assigned development programs. You will drive global regulatory strategy, provide leadership for regulatory activities...RegulatoryRemote job
- ...of Capital One, N.A., is seeking a Risk & Compliance Lead in New York City. The role is hybrid, with three in-office days (Mon, Wed, Thu) and up to four... ...weeks of fully remote work annually. You will drive regulatory compliance programs, partner with Legal, People, and GRC...RegulatoryWork at officeRemote work
$206k - $248k
...biotechnology company advancing gene therapies with curative... ..., Gene Therapy Clinical Science. The candidate... ...designs, high quality trial execution, and preparation... ...will be responsible for leading, developing, and managing... ..., and clinical-regulatory documents. Oversee and...RegulatoryTemporary workLocal areaShift work- ...and medical device company, seeks a Preclinical Principal Scientist to lead Preclinical Research Operations, including in vivo study design, vendor management, and regulatory strategy. This hybrid role involves off-site CRO work in the NY area, work from home, and on-site...RegulatoryWork from home
- ...Director of the Cardiovascular Division to lead strategic direction, development, and... ...programs. You will partner with Clinical, Regulatory, Commercial, and Medical affairs teams... ...staff, with a mix of office-based and hybrid work in New York and travel as needed to...RegulatoryWork at office
- ...collaborate with analytics and risk teams to optimize portfolios. You will lead with deep technical underwriting know-how, pricing discipline, and regulatory awareness while managing a book of business through market cycles in a hybrid work setting. #J-18808-Ljbffr SCORRegulatory
$63.09k - $70.12k
Clinical Research Regulatory Specialist B University Overview The University... ...Penn Neurogenetics Therapy Center (PNTC)... ...sponsored, first-in-human trials of genetherapies for... ...clinical trials, and/or gene therapyresearch is... ...assigned. The position is hybrid eligible and...RegulatoryLocal areaFlexible hours$100.8k - $151.2k
Operations Core Project Lead Analyst Apply (opens in new window) Job Req Id: 26952134 Location... ..., New York, United States Job Type: Hybrid Posted: Apr. 17, 2026 Discover your... ...Overview About the Organization SMBIC Data and Regulatory Operations Group is a global team...RegulatoryFull timeWork experience placementWork at office- ...Securities Valuation Office in New York. You will lead a team of credit analysts, review their... ...analyses for committee review. This hybrid, full-time role requires strong... ...travel as needed to support meetings and regulatory activities. Advanced finance credentials...RegulatoryFull timeWork at office
- ...A Time Care (ASAT) in Staten Island, NY seeks a BCBA to lead client programs in a hybrid work setting. You will develop ABA plans, supervise RBTs... ...achieve client success. You will ensure ethical practice, regulatory compliance, and contribute to ongoing professional...Regulatory
- ...Somerset, New Jersey, is seeking a Manager, Regulatory Project Management to support planning and execution of Cell & Gene Therapy programs. You will coordinate activities... ...Research, CMC, Quality, Regulatory Affairs, Clinical Operations and external partners to keep development...Regulatory
$144.8k - $217.2k
...discover and develop therapies that take aim at... ...suppressor gene loss and their contribution... ...Senior Manager, Clinical Data Management... ...Data Management lead for assigned clinical trials and is... ...trial execution, regulatory compliance, and... ...communication skills #LI-Hybrid We are an equal...RegulatoryFor contractors$176.72k - $265.08k
...Vice President, Network Benefits & Loyalty Lead In this highly visible role, you will sit... ...and benefits. Familiarity with the regulatory and litigation landscape affecting the card... ...with direct influence on business outcomes. Hybrid working model offering 3 days in the...RegulatoryFull timeContract workWork at officeRemote work$145k - $160k
...Location: Sommerset, NJ (Hybrid or Remote) About... ...bring new therapies to life. With over... ...programs , and 1,397 clinical trials across all phases.... ...s, biologics, and gene therapies and we work... ...-GCP, applicable regulatory requirements, and... ...departments. Lead and support internal...RegulatoryContract workTemporary workRemote workWorldwideFlexible hours- Qnity is seeking a seasoned Product Stewardship & Regulatory professional to lead global packaging EPR compliance. You will monitor regulatory changes, drive end‑to‑end reporting, and translate obligations into actionable internal requirements across Packaging Engineers...Regulatory
- United States Digital Space LLC in the clinical research sector seeks a Senior Specialist, Study Start Up and Regulatory Affairs to lead site initiation readiness and coordinate regulatory activities across regions. You will provide subject matter expertise, ensure ICH-...Regulatory
$190k - $240k
...company, is a global gene therapy leader focused on transforming... ...approved gene therapy clinical programs. They... ...as a team mentor, and lead national level initiatives... ...-Sponsored Trial (IST) requests and Early... ...internal and external regulatory and legal guidelines....RegulatoryLocal areaRemote workNight shift- ...is hiring a Director of Rehabilitation to lead a team of clinicians across physical, occupational, speech, and respiratory therapies. You will oversee rehab services, ensure quality... ...care, and mentor staff while maintaining regulatory compliance. The role emphasizes...Regulatory
- ...a Rehab Supervisor to oversee the productivity of field therapists and ensure compliance with regulatory standards. The ideal candidate will hold a valid NYS Physical Therapy or Occupational Therapy license and possess over 3 years of homecare experience. Strong interpersonal...Regulatory
- Citi seeks a Cross-disciplinary Controls Manager to lead a small team in Sao Paulo, overseeing end-to-end control activities, risk... ...in risk/control functions, strong leadership, and expertise in regulatory compliance and controls execution within financial services. #J...Regulatory
- ...underground water infrastructure projects in New York City. The role involves managing a multidisciplinary team, ensuring compliance with regulatory requirements and project specifications, and providing technical guidance on construction practices. The ideal candidate will...Regulatory
- ...practice as a senior technical specialist, leading complex projects and delivering... ...site investigations, remediation design, regulatory submissions, QA/QC, mentorship for junior... ...staff, collaboration across offices in a hybrid work environment, with a focus on NJDEP...RegulatoryWork at office
- Worldwide Clinical Trials is seeking an experienced Clinical Research Associate to oversee site activities across diverse therapeutic areas... ...supervision from Canada. You will manage site start-up, regulatory submissions, and TMF activities, while ensuring compliance,...RegulatoryWorldwide
- ...Full-Time Lead Therapist – Skilled Nursing Facility (Bronx, NY... ...patient outcomes while remaining clinically engaged. We offer competitive... ...therapists, as well as therapy aides Provide leadership and... ...performance Promote compliance with regulatory requirements and...RegulatoryFull time
- A small biotech company is seeking a Clinical Trial Manager (CTM) to lead early-phase oncology studies remotely. The ideal candidate will have at least... ...Lead. This role involves overseeing CROs, ensuring regulatory compliance, and supporting trials from start-up to close...RegulatoryRemote job
- ...seasoned Model Validation professional in the New York area for a hybrid role. You will validate complex models, assess risk, and provide independent challenge to ensure model integrity and regulatory compliance. You will partner with business units, oversee validation...Regulatory
- A leading medical organization in New York City is seeking an experienced... ...Medical Dosimetrist to oversee clinical and operational aspects of a high-volume proton therapy program. This mid-senior level... ...strong leadership skills. A hybrid work schedule is offered with requirements...2 days per week
- ...Description Job Description Lead Physical Therapist – Part-... ...Opportunity Outpatient Physical Therapy Practice | Brooklyn, NY A... ...launch, build, and grow the clinic together with the Practice... ...compliance with clinical, regulatory, documentation, and billing-related...RegulatoryFull timePart timeFlexible hours
$120k - $135k
Clinical Project Manager - Oncology (Client Dedicated... ...Health® is a leading fully integrated... ...the delivery of therapies, because we are passionate... ...oncology clinical trial experience to join... ...Monitoring, Regulatory Affairs, Safety,... ...oncology, and cell and gene therapy Join a...RegulatoryRemote jobContract workWork at officeImmediate startWorldwideFlexible hours
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