- University of Miami (Miami, FL)
- …from study start-up through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations. ... to investigators and their research staff to raise awareness of research compliance . Maintains current knowledge of applicable regulatory topics (eg,… more
- Cedars-Sinai (Beverly Hills, CA)
- …Responsibilities:** + Prepares and submits continuations and amendments to ensure compliance with regulatory requirements and institutional polices. + Advises ... to be a part of breakthrough research?** The Lead Regulatory Coordinator prepares and submits large and/or complex protocols...well as provides consultation to staff engaging in new clinical trails. + Develops and governs the standard operation… more
- Abbott (Plymouth, MN)
- …requirements and timelines to project teams. + Evaluate proposed preclinical, clinical , design and manufacturing changes for regulatory submission strategies. ... regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note:… more
- Bristol Myers Squibb (Indianapolis, IN)
- …for regulatory updates + Shadow cross-functional meetings to understand regulatory integration + Research and Compliance + Conduct literature reviews ... is a plus + Prior internship or coursework related to clinical trials or regulatory science **Skills and Attributes** + Detail-oriented and able to manage… more
- Abbott (San Diego, CA)
- …Recruit, develop, and mentor regulatory professionals. **Premarket:** + Approve regulatory filing strategies based on proposed preclinical, clinical , and ... guidance on regulatory requirements to development teams. + Manage preapproval compliance activities. + Formulate company procedures to respond to regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory , Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. ... therapies to patients worldwide. Join Takeda as an Senior Manager, Global Regulatory Affairs, CMC Small Molecules where you will oversee the development and… more
- Stanford University (Stanford, CA)
- …work direction to research support staff. * Demonstrated deep understanding of good clinical practices and regulatory compliance . * Demonstrated experience ... Post Date Jul 28, 2025 Requisition # 106946 The Clinical and Translational Research Unit (CTRU) is the leading...Develop and audit appropriate record keeping procedures and ensure regulatory compliance at every level. Provide direction… more
- Bristol Myers Squibb (Princeton, NJ)
- …Drug Promotion advisory submissions and sub part e submissions + Ensure full regulatory compliance of all promotions with approved labeling and /or FDA ... guidances + Ensure regulatory compliance with sub part e and...perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation,… more
- State of Massachusetts (Boston, MA)
- …analyses. * Oversee corrective action plans, patient complaints, and grievances to ensure regulatory compliance . * Serve as the organizational expert on Joint ... Commission accreditation standards and CMS conditions of participation; support policy compliance . * Interpret and communicate regulatory requirements, including… more
- Billings Clinic (Billings, MT)
- …and training. * Competency Maintenance: Ensures that required competencies for patient safety, clinical excellence, and regulatory compliance are met and ... enhance the quality of patient services through audits, reviews, and feedback. * Regulatory Adherence: Ensures compliance with all applicable laws, regulations,… more