- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Specialist , Regulatory Operations - Submissions supports the development of submission plans ... submissions to FDA and Health Canada. Relationships Reports to Management in Regulatory Operations and works cross-functionally...it takes an unordinary approach to drive real, lasting change in health. Novo Nordisk is an equal opportunity… more
- Delek US Holdings (Dallas, TX)
- Sr Regulatory DOT Compliance Specialist - Open to Field Location Location: Dallas, TX, US, 75024 Are you looking for a career in a dynamic and innovative company ... and innovative environment. **JOB INFORMATION** + Job Title: Sr Regulatory Affairs & Compliance Specialist + Job...Management + FLSA Status: Exempt + Job Function: Regulatory Affairs and Compliance + Job Level: Professional III… more
- Olympus Corporation of the Americas (Westborough, MA)
- …more about Life at Olympus: https://www.olympusamerica.com/careers . **Job Description** The Sr. Regulatory Affairs (RA) Specialist II Digital Health supports ... As part of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance, prepare...dashboard updates concerning current pending and future approvals for Regulatory Affairs management . + As needed assist… more
- Teleflex (Morrisville, NC)
- Senior Regulatory Affairs Specialist **Date:** Nov 3, 2025 **Location:** Morrisville, NC, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,... issues and impacts. - Interact and negotiate with regulatory authorities during the development (ie Q-Sub, change… more
- The Clorox Company (Willowbrook, IL)
- …**Your role at Clorox:** The Senior Regulatory Specialist will serve as ... development and implementation of effective documentation and data control management for compliance files within the Regulatory ...C: $88,900 - $170,800 All ranges are subject to change in the future. Your recruiter can share more… more
- Xcel Energy (Santa Fe, NM)
- …be just what you're looking for. **Position Summary** Work directly with senior management to develop regulatory case filings and strategies that support the ... consistent with company goals. Communicate and work effectively with regulatory case management teams to ensure filings...Off (VPTO), Parental Leave Benefit plans are subject to change and Xcel Energy has the right to end,… more
- embecta (Parsippany, NJ)
- … management activities which include identification and interpretation of regulatory requirements, review and preparation of regulatory submissions required ... diverse and global employees. This position will be responsible for providing regulatory strategies and execution on embecta growth initiative projects. The role… more
- Aequor (Framingham, MA)
- Shift: 1st Work Schedule: Mon-Fri 800-430The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring ... excellence in quality standards and regulatory compliance across external partnerships. This role requires leading Supplier Change Notification (SCN) processes,… 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. ... experience working with suppliers would be a home run candidate. Basic project management skills required.The Specialist Manufacturing is expected to own and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Rahway based Senior Specialist , Global Development Quality Operations, is responsible for independent approval of documentation to support GMP ... components, and critical supply items to ensure conformance to appropriate regulatory and company requirements. In support of clinical supply manufacture and/or… more
- Merck & Co. (Durham, NC)
- …Maintenance, Automation, and Quality approvers.- As part of the deviation management role, present and defend investigations during regulatory inspections, ... and Skills: Proficient in PI Processbook, Siemens BAS, and DeltaV Project management , including change control and equipment qualification SAP experience related… more
- Cipla (Fall River, MA)
- Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM ... : Quality Assurance Manager Salary Range: $72,800 - $93,600 Purpose: The QA operation specialist (MDI) position is an individual contributor role and a member of the… more
- Merck & Co. (Rahway, NJ)
- …Machinery, Automation Engineering, Automation Solutions, Biopharmaceutical Industry, Capital Project Management , Capital Projects, Change Management , ... Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality engineering support for the Rahway, NJ FLEx (Formulation, Laboratory &… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Operations Specialist as part of the Technical Operations team based in Raritan, NJ.Role ... to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data … more
- embecta (Parsippany, NJ)
- …during audits. **Basic Requirements:** + 5+ years of document control and change management experience in Medical Device or Pharmaceutical. + Bachelor's ... Reporting directly to the Manager of Document & Data Management , the Quality Specialist of Document ...applicable regulations. + Proficient knowledge of Document Control and Change Management . + Experience in systems such… more
- Merck & Co. (Rahway, NJ)
- …, quality and other supply chain areas to address clinical supply and/or change management related topics. Responsible and accountable for establishing the ... #eligibleforERP GCScareers GCScareer25 #PSCS #VETJOBS Required Skills: Adaptability, Adaptability, Change Control Processes, Change Management , Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …and operational efficiency of validated systems through participating in release management , change control, periodic reviews, and audit trail reviews.What ... projects at the same time. Provide operational support like change controls, release management , and reviews of...Provide operational support like change controls, release management , and reviews of validated systems. Author CSV Documents… more
- Cipla (Fall River, MA)
- …manufacturing/engineering non-conformance. Review and approval of manufacturing /engineering change controls, deviation investigations and CAPAs. Reviews and ... documents. Provides daily/weekly updates to the shop floor and management regarding quality highlights/concerns. Creates lessons learned for training as… more
- Stanford Health Care (Palo Alto, CA)
- …Health Care job.** **A Brief Overview** Clinical Government Audit Analyst and Appeal Specialist II plays a critical role in the Revenue Cycle Denials Management ... understanding and application of clinical documentation standards, coding, and regulatory requirements, as well as excellent analytical and communication skills.… more
Related Job Searches:
Change,
Change Management,
Change Management Specialist,
Management,
Management Specialist,
Regulatory,
Regulatory Change Management,
Specialist