- MD Anderson Cancer Center (Houston, TX)
- …will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and applications. They will oversee a team of ... regulatory specialists responsible for advising MD Anderson's investigators on FDA submission requirements and pathways, develop investigational plans and protocols,… more
- Sumitomo Pharma (Austin, TX)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs** . The Director is part of the Global ... company. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This… more
- Sumitomo Pharma (Austin, TX)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs** . The Associate Director is part of the ... Activities** + Leads preparation, coordination, authoring and monitoring of submissions (eg, BLA/IND/NDA submissions , annual reports, investigator brochures,… more
- Danaher Corporation (Dallas, TX)
- …report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be responsible for developing and executing ... role, you will have the opportunity to: + Lead regulatory submissions , including pre-market applications, product registrations, post-approval updates, by ensuring… more
- Takeda Pharmaceuticals (Austin, TX)
- …for drug development. + Demonstrated track record of successful interactions with FDA , EMA, Notified Bodies, and other global health authorities specifically related ... to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA,...SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements). + Understanding of scientific principles… more
- United Therapeutics (Austin, TX)
- …and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, ... other orphan diseases. **How you'll contribute** The Associate Global PV Case Management Director plays a key role in management and oversight of end-to-end case… more
- Houston Methodist (Houston, TX)
- …sponsor's regulatory team. This position communicates with regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas ... performing study specific regulatory processes such as local IRB and external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state,… more
- Takeda Pharmaceuticals (Austin, TX)
- …Data Process Excellence and Delivery based remotely reporting to the Senior Director , Integrated Clinical Trial Data Process Excellence and Delivery. At Takeda, we ... quality, regulatory compliant data in support of publications and regulatory submissions . + In partnership with functional stakeholders and with Global Development… more