- Otsuka America Pharmaceutical Inc. (Austin, TX)
- …potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements ( FDA , EMA, ICH). + Familiarity with ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- Justice, Bureau of Prisons/Federal Prison System (TX)
- …in accordance with local and Federal laws, Food and Drug Administration ( FDA ), and Joint Commission regulatory standards, directives and professional guidelines. ... Biomedical Department according to equipment standards, patient safety parameters, and regulatory requirements. Assists in the management of the Medical Center… more
- TreeHouse Foods, Inc. (Northlake, TX)
- …improvement projects. + Strong understanding of food safety, quality systems, and regulatory requirements ( FDA , SQF, etc.). + Excellent problem-solving, project ... evaluate and validate cost-reduction ideas without compromising product quality or regulatory compliance. + Conduct root cause analysis and implement corrective… more
- TreeHouse Foods, Inc. (Northlake, TX)
- …for customer meetings. + Ensure all activities follow established safety standards, regulatory requirements ( FDA , UDSA & Kosher) and Good Manufacturing ... Procedures (GMP). **_Important Details:_** + This is a full-time, on-site role on first shift. **_You'll fit right in if you have:_** + 2+ years of experience in Food Science Product Development or related field. + Knowledge of ingredient… more
- Baylor Scott & White Health (Plano, TX)
- …research programs. + Monitors communication with the IRB, Food and Drug Administration ( FDA ), and other applicable regulatory agencies. **Key Success Factors** + ... Research certification or other certifications per specialty area preferred. + Basic Life Support (BLS) per department requirements. + Proven written and oral communication skills. + Proven computer skills, including Microsoft Office, Excel, and PowerPoint. +… more
- MD Anderson Cancer Center (Houston, TX)
- …research tracking and compliance purposes. * Observe and support the assembly of regulatory documents per local and FDA regulations, institutional SOPs, and ... *Coordinator, Clinical Research Regulatory - Leukemia* *MISSION STATEMENT* The mission of...compliance with all applicable regulations, guidelines, and standards (eg, FDA , GLP). * Coordinate and manage the informed consent… more
- UTMB Health (Galveston, TX)
- Regulatory Scientist I / II - Institutional Office of...FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as a ... UTMB Health Requisition # 2402210 **JOB DESCRIPTION** Function: The Regulatory Scientist II will be assigned as a Study...as a Study Director, as defined by the US FDA Good Laboratory Practice (GLP) regulations (21CFR58), and will… more
- Sumitomo Pharma (Austin, TX)
- …and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and ... highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations, For assigned projects, the Senior Manager of Regulatory … more
- Fujifilm (College Station, TX)
- …of program quality activities per approved Quality Agreements, and ensure compliance with FDA , EU, and other relevant regulatory bodies. + Work with functional ... general directions only for new assignments. + Familiarity with regulatory standards, including cGMP, FDA , EU, and...+ Familiarity with regulatory standards, including cGMP, FDA , EU, and risk management practices. + Effectively adapts… more
- Bio-Techne (Austin, TX)
- …labeling, promotional, and advertising materials. + Develop and execute global regulatory strategies, ensuring compliance with FDA and international medical ... skills, and ability to manage workload independently. + Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and… more