- Taiho Oncology (Pleasanton, CA)
- …of Statistical Analysis Plans. + Collaborating with Clinical Development, Biostatistics, Clinical Operations and Regulatory to incorporate the bioanalysis for PK ... of the following documents: + Clinical Study Reports. + Investigator Brochures. + Regulatory Documents, including NDAs and MAAs and responses to questions from … more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …+ Cross-Functional Collaboration: Partner with regional quality leaders, manufacturing, regulatory affairs, and technical operations to ensure alignment ... systems are aligned with **Good Manufacturing Practices (GMP)** and regulatory requirements while driving **efficiency, consistency, and continuous improvement**… more
- Bristol Myers Squibb (Indianapolis, IN)
- …of RayzeBio's Quality Management System and ensures readiness for regulatory inspections and commercial operations . **Job Responsibilities** Essential ... with the audit program. + Evaluate compliance with applicable regulatory requirements (eg, FDA, EMA, ICH), internal SOPs, and...are generally not available for field sales and manufacturing operations and may also be limited for the capability… more
- Merck (West Point, PA)
- …in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations , Technical, or Regulatory function supporting manufacturing ... troubleshooting where cross-functional investigation is required. + Technical SME for regulatory questions, audit support, reagent changes / supply issues to… more
- Simplot (Boise, ID)
- …advice and support for both project initiatives and business-as-usual ("BAU") operations . Prioritize regulatory alignment and proactive risk management. + ... with Legal, Business, and HR leaders to ensure labor relations regulatory compliance, build labor relations capability, manage risk, and foster constructive,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …of combination products and drug delivery devices. + Engage actively with Product Operations , Quality, Regulatory , and External CMO Operations & Supply ... products and lifecycle management. + Collaborate closely with R&D, Quality, Regulatory , Procurement, and External Supply Teams to support seamless device lifecycle… more
- BrightSpring Health Services (Indianapolis, IN)
- …and organizations we serve. The QAC plays an integral part in ensuring the operations meet regulatory and contractual compliance. The QAC will provide support to ... Federal and BrightSpring Health requirements. The QAC provides leadership oversight to operations in meeting operational goals and ensure safety and satisfaction for… more
- East Boston Neighborhood Health Center (East Boston, MA)
- … and payer expectations. The ideal candidate will have experience in pharmacy operations and regulatory setup, mastery of 340B program HRSA requirements, a ... dedicated teams, or part of the essential support staff who keep our operations running smoothly - every role at NeighborHealth is vital. Together, we're advancing… more
- Lowe's (Mooresville, NC)
- **Your Impact** The primary purpose of the Senior Manager, Regulatory Affairs and Marketplace Compliance is to lead the development and operationalization of our ... and overseeing policies, processes, and controls that ensure compliance with regulatory requirements, internal policies, and industry best practices. The role… more
- Tenet Healthcare (Detroit, MI)
- Regulatory Manager Full Time Days - 2506002316 Description : DMC Sinai-Grace Hospital is DMC's largest hospital, offering a comprehensive heart center, cancer care, ... with market leadership, is responsible for overseeing and monitoring DMC operations to ensure adherence with applicable statutorial, governance and regulatory… more