- 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
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …organizations. **Knowledge, skills, & abilities:** Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of ... global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet… more
- TEKsystems (Austin, TX)
- …US Customs programs including Antidumping and Countervailing Duty Orders, and PGAs (eg FDA , EPA.) * Proficiency with MS Office and SAP-GTS. Skills trade compliance, ... import compliance, import, sap, tableau, hts Top Skills Details trade compliance,import compliance,import,sap,tableau,hts Additional Skills & Qualifications * Support Apple's Global Trade classification program and other classification teams globally. o… more
- United Therapeutics (Austin, TX)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- Sumitomo Pharma (Austin, TX)
- …oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and ... marketed products. The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our… more
- Abbott (San Antonio, TX)
- …developments + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, company policies, operating procedures, processes, ... and task assignments + Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors **Required Qualifications** + Bachelors Degree ( +/- 16 years) or an equivalent combination of… more
- Abbott (Austin, TX)
- …+ Develops and implements engineering systems and procedures to ensure compliance with FDA , GMP, and other applicable regulations. + Ensures a safe work environment ... consistent with Environmental, Health & Safety requirements and company policies. **Required Qualifications** + Bachelor's degree in engineering or adjacent technical field. + 7-9 years of related work experience or an equivalent combination of education and… more
- Sysco (New Braunfels, TX)
- …Complies with local, state and federal regulatory agencies (ie OSHA, AIB, FDA , USDA, etc.) **QUALIFICATIONS** **Education** + High school diploma or general ... education degree (GED). + 2 or 4-year college degree in Business Management, Supply Chain Management or similar major preferred. **Experience** 3-5 years related experience and/or training; or equivalent combination of education and related experience.… 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** ... tasks **GROWTH/INNOVATION ESSENTIAL FUNCTIONS** + Participates with the Quality Assurance Manager and/or cGMP Core Director in defining quality policies. + Assists… more
- Actalent (Fort Worth, TX)
- Job Title: Quality/Regulatory Manager Job Description The Head of Quality & Regulatory Affairs is responsible for leading and managing all aspects of quality ... vigilance, and recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies, and Health Canada. + Develop, implement, and maintain policies,… more