- Dow (Houston, TX)
- At a glance Position: FDA Product Regulatory Manager Primary Location:Midland (MI, USA), Michigan, United States of America Additional Locations: Freeport ... 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… more
- Sumitomo Pharma (Austin, TX)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager ... Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment Registrations, Drug Product Listings). +… more
- Grifols Shared Services North America, Inc (Fort Worth, TX)
- …and initiatives that significantly impact the business. + Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies ... more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has… more
- Wolters Kluwer (Coppell, TX)
- **Lead Technology Product Manager ** - Commercial Drug Information This role follows a hybrid model, offering the flexibility to work remotely while staying ... **SUMMARY** As part of the **Wolters Kluwer Health team** , the **Lead Technology Product Manager for Medi-Span** plays a critical role in advancing our… 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 ... present to cover hours of operation in adherence to regulatory requirements and to minimize donor wait times during...protocols and maintains IQPP Viral Marker Standards. + Ensures FDA licensed product ; SISPQ (strength, identity, safety,… 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 ... may have! **JOB SUMMARY** Assists and supports the Center Manager in the daily operations of a plasma collection...within the scope of EU Good Practice Guidelines and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has… more
- Danaher Corporation (Austin, TX)
- …related to Good Clinical Practice with hands on experience in dealing directly with FDA and other regulatory agencies + Proven track record of managing ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Manager , Clinical Quality and Compliance reporting to the Senior… more
- Kedplasma (Houston, TX)
- …ensures corrective action(s) as needed. . Responsible, in collaboration with the Center Manager , for overseeing all activities related to product quality, and ... DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA , EMEA, Customer...and meeting(s) in a timely manner as instructed by supervisor/ manager . . Cooperate with department personnel, as well as… more
- Fujifilm (College Station, TX)
- …of program quality activities per approved Quality Agreements, and ensure compliance with FDA , EU, and other relevant regulatory bodies. + Work with functional ... routine tasks and general directions only for new assignments. + Familiarity with regulatory standards, including cGMP, FDA , EU, and risk management practices. +… more
- Fujifilm (College Station, TX)
- **Position Overview** The Manager , CSV will be responsible for management, scheduling, and oversight of all GxP-Regulated Computerized Systems at all applicable ... points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data… more