- Parexel (Montgomery, AL)
- …new, and marketed small molecule products are developed and maintained in compliance with global regulatory requirements. The primary regions of responsibility ... experienced and highly motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory ...Global Regulatory Affairs team as a CMC Regulatory Affairs Senior/Consultant. This role is critical to ensure… more
- Formation Bio (New York, NY)
- …to develop and implement a comprehensive quality assurance strategy that ensures compliance with regulatory requirements and industry best practices to support ... you will establish and manage the organization to ensure our organization's compliance with the highest standards, including Good Manufacturing Practices (GMP), Good… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and collaboration across relevant cross functional groups to enable robust training, regulatory compliance , team readiness, and processing of product prior to ... release to patients.Schedule: Mon-Fri, 2nd Shift#Li-OnsiteThe anticipated base pay range is$46,467—$60,989 USDBenefitsWe are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in… more
- CSL Behring (Waltham, MA)
- …and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance . Identify and proactively manage risk with ... function. Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements to support project needs. Contribute… more
- CSL Behring (Waltham, MA)
- …and implementation of bioanalytical/biomarker assays, ensuring scientific rigor, robustness, and regulatory compliance . Identify and proactively manage risk with ... function. Ensure best practices in experimental design, data analysis, and compliance with regulatory requirements to support project needs. Contribute… more
- Terumo Medical Corporation (Somerset, NJ)
- …3. Demonstrated ability to independently lead complex labeling projects, balancing regulatory compliance , business needs, and timelines. 4. Expert application ... labeling requirements across US and international markets and ensures compliance with FDA, Terumo, and global regulatory ...ensures compliance with FDA, Terumo, and global regulatory standards. The Senior Labeling Specialist II functions as… more
- Sunrise Senior Living (Charlottesville, VA)
- …staffing and scheduling patterns to maintain continuity of guest/resident care and regulatory compliance * Assesses and monitors clinical setting for effective ... or responsible party during difficult transitional care periods. Quality Assurance and Regulatory Compliance * Strives for excellent quality care and service… more
- Caris Life Sciences (Phoenix, AZ)
- …audit readiness. The role operates within Caris' global Quality System and Regulatory framework, maintaining compliance with applicable FDA, ISO 13485, CAP, ... Subject Matter Expert (SME) for Complaint Handling, CAPA integration, and related regulatory reporting (MDR, PMS), ensuring compliance , accuracy, and consistency… more
- Merck & Co. (North Wales, PA)
- …marketing support of pharmaceutical products Deep knowledge of our company's commercial, regulatory , and legal compliance policies Experience in the company ... will be in the areas of promotional review process management, Pharmacovigilance and Compliance point for department. - Senior Specialist partners with our US Hub… more
- Hawaiian Electric (Honolulu, HI)
- …related minimum filing requirements across the Companies. Works closely with the Regulatory Department to ensure regulatory compliance reporting, oversight ... Professional) JOB FUNCTION: Responsible for the planning and management of regulatory accounting activities for the Customer Service departments and General Counsel,… more
