- Otsuka America Pharmaceutical Inc. (Austin, TX)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- Kedplasma (El Paso, TX)
- …with KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...present to cover hours of operation in adherence to regulatory requirements and to minimize donor wait times during… more
- Canon USA & Affiliates (Austin, TX)
- ** Regulatory Affairs Specialist - Post Market - req1434** **OVERVIEW** Reporting to the Director Regulatory Affairs, the Regulatory Affairs Specialist is ... of reportable events + Provide information as requested for the filing of FDA recalls + Coordinate FMI process, including monitoring and reporting status and… more
- Fujifilm (College Station, TX)
- …Develop and implement microbiological quality control procedures to ensure compliance with FDA , EMA, and other relevant regulatory guidelines. + **Data ... maintaining a contamination-free environment, support our product pipeline, and ensure regulatory compliance. **Company Overview** The work we do at FUJIFILM… more
- Grifols Shared Services North America, Inc (Longview, TX)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions… more
- Honeywell (Houston, TX)
- …transfer streamlining, batch execution and recipe management, quality management systems, regulatory compliance (GMP, FDA , EMA), manufacturing analytics, digital ... critical challenges including technology transfer, batch execution, quality management, regulatory compliance, and operational efficiency. **Key Responsibilities** Lead and… more
- IQVIA (Austin, TX)
- …that work delivered to clients meet minimum submission requirements as defined by FDA Guidance Documents and other regulatory guidance. + Guide clients in ... standards and study specifications that align to the CDISC standards and regulatory agency guidance's. This position provides this guidance and training to clients… more
- Cytel (Austin, TX)
- …with Bayesian methods preferred. + Ensure quality and compliance with internal standards and regulatory guidelines (eg, FDA , EMA, ICH). **Here at Cytel we want ... complex manufacturing data to ensure product quality, consistency, and regulatory compliance. **As a Principal Biostatistician, your responsibilities will include:**… more
- Kedplasma (Dallas, TX)
- …with KEDPLASMA SOPs and other company standards and protocols to meet the regulatory requirements of the FDA , EMEA, Customer Specifications, and other ... within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...plasma operations and business processes preferred. + Knowledge of FDA , CLIA, and cGMP regulations related to plasma donation… more
- ZOLL Medical Corporation (Dallas, TX)
- …and internal training + Knowledge of industry specific cybersecurity frameworks and regulatory requirements such as FDA Pre and Post-market Guidance on ... the design of security-related features, and the delivery of cybersecurity regulatory requirements. + Assist with SBOM management utilizing enterprise-wide tooling.… more