- 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
- Actalent (Fort Worth, TX)
- …ensure consistent implementation of quality systems. Essential Skills + Medical device quality assurance + FDA regulatory affairs + Process and equipment ... Job Title: Quality / Regulatory Manager Job Description The Head...post-market surveillance, vigilance, and recall activities. + Liaise with regulatory agencies such as FDA , Notified Bodies,… 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
- 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
- Sumitomo Pharma (Austin, TX)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… 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
- 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
- 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
- Actalent (Grand Prairie, TX)
- …international markets. Key Responsibilities + Ensure laboratory practices comply with FDA , Health Canada, and international regulatory requirements + Maintain ... within the OTC drugs OR Cosmetics *REQUIRED* + Strong understanding of regulatory frameworks, label review, FDA registration, and documentation standards +… more
- Grifols Shared Services North America, Inc (Fort Worth, 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...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more