- Sumitomo Pharma (Springfield, IL)
- …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
- Astellas Pharma (Northbrook, IL)
- …best practices regarding planning and execution of promotional strategies. + Approves FDA 2253 submissions and advises the Regulatory Operations group regarding ... the requirements for promotional materials as set forth by FDA . Develops and maintains a positive working relationship with...science, and the ability to apply that knowledge to regulatory issues and product development having technical… more
- FREEMAN (Chicago, IL)
- …The ideal candidate will have a strong background in engineering, safety, and regulatory compliance. You will lead the product management structures team and ... + Testing and Validation: Develop and execute testing plans to validate product performance, safety, and regulatory compliance. + Documentation: Maintain… more
- GE HealthCare (Chicago, IL)
- … strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and ... strategy and direction for the ARC business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and… more
- Grifols Shared Services North America, Inc (Carbondale, IL)
- …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 (Riverwoods, IL)
- **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
- US Tech Solutions (North Chicago, IL)
- …and maintain **complaint files,** in compliance with regulations established by the FDA and international regulatory bodies, and submit safety reports to ... in compliance with all internal requirements and with all applicable regulatory requirements, including knowledge of operating in a controlled environment per… more
- Sumitomo Pharma (Springfield, IL)
- …clinical trial and post-market ICSRs. + Experienced in supporting partner audits and regulatory inspections including FDA , MHRA, and EMA. + Proficient in ARGUS, ... highly motivated, and experienced individual for the position of **Associate Manager , Compliance, Training & Strategic Alliance (CTSA), PVRM** . The Associate… more
- Cardinal Health (Glendale Heights, IL)
- …experience in a quality management role preferred. + Thorough knowledge of FDA regulatory requirements, controlled environments, good manufacturing practices and ... cGMP's and regulatory requirements. + Collaborates with their assigned Area Manager and others to build strategic alliances within the PET network; negotiates to… more
- Whitsons Culinary Group (Berkeley, IL)
- … quality and dietary compliance + Ensure documentation and reporting meet standards for regulatory bodies (DOH, USDA, FDA , Joint Commission, etc.) + Respond to ... + Develop, implement, and monitor FSQA programs aligned with regulatory , co mpany , and client standards + Train...: + Minimum 5 years' experience as a QA Manager in a high-speed multi product lines… more
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