- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport (TX, USA) ... Type:Regular Workplace Type:Remote or Hybrid or Onsite Apply Now (https://dow.wd1.myworkdayjobs.com/ExternalCareers/job/Midland-MI-USA/ FDA -Product-Regulatory-Manager\_R2060938/apply) Return to Job Finder At Dow, we believe… more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Fotona (Irving, TX)
- …to lead regulatory and corporate compliance efforts, with a strong focus on FDA readiness and enterprise-wide policy governance as we expand our US presence. This ... resilience in a dynamic, fast-paced environment. Key Leadership Responsibilities: Regulatory & FDA Compliance Strategy + Serve as the organizational lead for all … more
- Houston Methodist (Houston, TX)
- …Research Institute Institutional Review Board (IRB), Food and Drug Administration ( FDA ) Code of Federal Regulations (CFR), and the International Conference on ... Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases… more
- Kedplasma (El Paso, TX)
- …developed and maintained. Operates within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other regulatory bodies, as required. + Maintains… more
- MD Anderson Cancer Center (Houston, TX)
- …* Ensure compliance with all applicable regulations, guidelines, and standards (eg, FDA , GLP). * Coordinate and manage the informed consent process for clinical ... * Participate in audits and reviews, including shadowing assignments. * Support FDA submissions and participate in assigned research audits. * Maintain schedules for… more
- Houston Methodist (Houston, TX)
- …inspections and audits to ensure compliance with Federal Drug Administration ( FDA ) regulations and cGMP Core policies and procedures. **FINANCE ESSENTIAL FUNCTIONS** ... positive language principles + Familiar with quality, compliance and FDA regulatory requirements for Good Laboratory Practice (GLP) and...(21 CFR Parts 210/211, Medical Device Regulations, ICH and FDA guidances, etc.) and the ability to apply them… more
- Danaher Corporation (Austin, TX)
- …GCP auditing (ie, TMF, SOP compliance, training, etc.), interface to the FDA and notified bodies, clinical CAPA management, and IVDR compliance across Clinical ... thorough knowledge of current international requirements of GCP, GLP, FDA , ICH, EU, and applicable global regulations to ensure...Practice with hands on experience in dealing directly with FDA and other regulatory agencies + Proven track record… more
- UTMB Health (Galveston, TX)
- …Scientist II will be assigned as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will serve as the single point ... and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize...regulations or under quality systems that utilize the US FDA GLP regulations as a reference standard. The Regulatory… more
- Fujifilm (College Station, TX)
- …in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Bachelor's Degree with 4+ years of direct ... in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA -regulated environments, OR; + Associates Degree with 6+ years of direct… more