- Merck & Co. (Philadelphia, PA)
- … Management , Quality Management , Regulatory Affairs Compliance, Regulatory Change Management , Regulatory Communications, Regulatory ... Job DescriptionDescription The Associate Specialist of Regulatory Planning & Publishing...Regulatory Management , Regulatory Project Management , Regulatory Strategies, Regulatory Strategy… more
- Aequor (Thousand Oaks, CA)
- …(SICAR /EN), and Change Control) under the company's quality management system procedures and ensures compliance with regulatory agency requirements. ... Preferred experience managing in Track Wise or Veeva Systems Basic project management skills required. The Specialist Manufacturing is expected to own… more
- Capital One Bank (Washington, DC)
- Manager, Systems Specialist OperationsThis is an exciting opportunity to partner with world class professionals to solve real business problems while acting as a ... goals. You will also be responsible for application system and process management initiatives, and for ensuring applications are in compliance with applicable … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Investigator Compliance Specialist as part of the Technical Operations team based in Raritan, NJ. ... member of the Technical Operations team, responsible for ensuring adherence to regulatory requirements and internal quality standards across cell and gene therapy… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Specialist to support operations for enzyme process development and characterization. Our ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes. The Specialist will execute scientific and operational activities to support the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …implementation of new policies and procedures within Sourcing & Procurement.Drives change management and develop training materials and internal communications ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Buyer/ Planner Specialist as part of the Technical Operations team based in Raritan, NJ.… more
- Aequor (Athens, GA)
- …results in validation report Collaborate with the area manager(s) for project management , project timelines, regulatory documentation and final reports for ... to the USDA Skills: Experience with analytical method validation and regulatory method validation requirements (USDA, ICH, FDA) Preferred experience in writing… more
- Merck & Co. (Durham, NC)
- …Manufacturing Processes, Problem Management , Production Support, Quality Management , Real-Time Programming, Regulatory Inspections, Software Development Life ... Development, Technical Services, Utilities and Validation. Position Description: The Senior Specialist , is a member of the Focus Factory Automation team responsible… more
- Genentech (South San Francisco, CA)
- …health authorities, based on current regulatory knowledge and expertise. As a Regulatory Program Management Specialist in the Program Management ... the PDR Program Management Chapter, we are responsible for delivering global regulatory strategy and end to end execution of clinical projects in the Roche… more
- BD (Becton, Dickinson and Company) (Warwick, RI)
- **Job Description Summary** The Staff Regulatory Affairs Specialist - BD Excellence position reports directly to the BD Interventional Segment's Surgery VP ... portfolios. Through collaboration and communication with key stakeholders, the Staff Regulatory Affairs Specialist - BD Excellence will successfully negotiate… more
- Teleflex (Morrisville, NC)
- …costs, and enhance product margins. Under Strategic Regulatory Affairs Team Management , the Senior Regulatory Affairs Specialist will develop strategies ... Sr Regulatory Affairs Specialist **Date:** Sep 23,...implementation plans. * Manage Technical Documentation. * Manage Global regulatory impact assessments. * Review and assess change… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …well independently and as part of a team. The Staff Regulatory Affairs Specialist will work in BD - Specimen Management providing regulatory leadership ... your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused... management activities for PreAnalytiX and Lab Specimen Management products, including assessment of the regulatory … more
- Actalent (St. Louis, MO)
- Quality Engineer III/ Regulatory Compliance Specialist Job Description The Regulatory Compliance Specialist plays a crucial role in ensuring the ... in audits and inspection readiness. + Experience with Quality Systems, including change control, root cause analysis, deviations, documentation management , and… more
- Medtronic (Minneapolis, MN)
- …in a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST ** _Location: Minnesota Rice Creek East Facility (Minimum ... therapies that we provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory … more
- Mount Sinai Health System (New York, NY)
- …industry experience preferred, especially in the areas of quality or regulatory management , project management , and/or change management . CPHQ, Lean ... **Job Description** **Quality and Regulatory Specialist MSH Quality Assurance FT...Systems** 1. Supports an information system for quality and regulatory management data collection, data aggregation, and… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and services in more than 110 countries and regions. **Summary:** The Regulatory Affairs Surveillance Specialist will determine and execute actions necessary ... the ability to propose solutions or escalate to upper management . + Review, monitor and coordinate regulatory ...is aware on the status of submissions/applications. + Provide regulatory assessment on change controls for proposed… more
- Houston Methodist (Houston, TX)
- At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific ... Procedures (SOPs), and study specific protocols/plans and processes. The Sr Regulatory Compliance Specialist position maintains documentation for clinical… more
- Commonwealth Care Alliance (Boston, MA)
- …* Document and track all regulatory inquiries, escalations, and resolutions. Change Request Management & System Configuration * Draft detailed ServiceNow ... to the Director, Claims Operations & Quality Assurance, the Regulatory Compliance & Audits Sr. Specialist II...to have): * Facets (Core Claims Platform) * ServiceNow ( Change Request Management ) * Salesforce (Dispute/Compliance Tracking)… more
- Teleflex (Morrisville, NC)
- Regulatory Affairs Specialist **Date:** Sep 9, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ID** ... make a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and...regulatory submissions and compliance. * Review and assess change control activities for potential impact on current … more
- Abbott (St. Paul, MN)
- …female executives, and scientists **The Opportunity** We are seeking a **Principal Regulatory Affairs Specialist ** to join Abbott's Vascular Division on-site in ... the treatment of vascular disease. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the … more
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