- 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, USA) ... 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, we believe… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will ... help the FDA meet its obligations under recent legislation and ensure...Responsibilities: + Oversee daily operations and maintenance support for FDA electronic submission systems and mailboxes. + Manage and… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will ... help the FDA meet its obligations under recent legislation and ensure...ensuring timely resolution or escalation of tickets related to FDA submission platforms. The analyst applies analytic methodologies to… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will ... help the FDA meet its obligations under recent legislation and ensure...SLAs and performance metrics, and effective cross-desk coordination for FDA /CDER. This role manages the SOP and FAQ repository,… more
- DRT Strategies, Inc. (Silver Spring, MD)
- …supporting data quality, and helping with process improvements so that the FDA can efficiently review submissions and maintain business continuity. This support will ... help the FDA meet its obligations under recent legislation and ensure...analyzing business needs, documenting processes, and ensuring compliance with FDA requirements for electronic submissions and data management. This… more
- Boehringer Ingelheim (Ridgefield, CT)
- …draft CCDS. + Provide US guidance to the global team on FDA submissions, meetings, and pediatric development requirements, including documentation preparation. (3) ... teams during development, registration, and marketing approval considering regulatory precedence and FDA guidance. + Contribute to US RA efforts on draft labeling… more
- Boehringer Ingelheim (Ridgefield, CT)
- …of regulatory activities required of an IND/NDA/BLA Holder for compliance to FDA requirements for BI's investigational and US market product portfolio. These ... of original and/or supplemental applications and post marketing reports per US FDA regulations. The Associate Director, US Product CMC Regulatory Affairs acts as… more
- TekSynap (Silver Spring, MD)
- …Diagnose and resolve routine hardware and software issues. + Research questions using the FDA Help Desk Knowledge Base, the FDA Intranet, and other available ... of tickets once resolution has been confirmed. + Install and configure FDA qualified products and upgrades. These could include applications, software, utilities,… more
- 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
- Abbott (Santa Clara, CA)
- …regulations and experience such as from the Food and Drug Administration ( FDA ) Center for Devices and Radiological Health (CDRH). This Senior Manager Regulatory ... device business units for new products or changing existing products especially with FDA + Supports and provide critical review of key documents necessary for… more