- 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, ... 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,… more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... **SERVICE ESSENTIAL FUNCTIONS** + Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA , GCP, NIH… more
- Houston Methodist (Houston, TX)
- …and the International Conference on Harmonization (ICH). This position communicates with regulatory affairs office for FDA submissions across multiple studies of ... identified by the Manager. Assists in the preparation of periodic reports for FDA + Develops appropriate regulatory reports and associated documentation in… more
- UTMB Health (Galveston, TX)
- …funding agencies to design and execute regulated nonclinical studies compliant with the US FDA GLP regulations or under quality systems that utilize the US ... FDA GLP regulations as a reference standard. The Regulatory Scientist I / II may also function as a Principal Investigator for extramurally funded research… 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 ... - Master's Degree EXPERIENCE REQUIRED - 3 years experience in clinical research, regulatory compliance, or quality assurance OR 1 year experience in clinical… more
- 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
- United Therapeutics (Austin, TX)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Merck (Austin, TX)
- …+ Oversee and independently lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all ... documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written communications. +… more
- Actalent (Grand Prairie, TX)
- …international markets. Key Responsibilities + Ensure laboratory practices comply with FDA , Health Canada, and international regulatory requirements + Maintain ... Affairs within the OTC drugs OR Cosmetics *REQUIRED* + Experience with regulatory frameworks, label review, FDA registration, and documentation standards +… more
- Houston Methodist (Houston, TX)
- …customer service focus and application of positive language principles + Familiar with quality , compliance and FDA regulatory requirements for Good ... will be responsible for all aspects of compliance associated with the quality operations including, but not limited to, review of procedures, verification of… more