- Aldevron (Miami, FL)
- …and procedures and collaborating with cross-functional teams, including Clients, Regulatory Affairs, and Marketing, to develop labeling strategies that align ... with regulatory requirements and company branding.In this role, you will...creation, issuance, and reconciliation. Implement control mechanisms, such as document control, change management, and review cycles, to maintain… more
- Integrated DNA Technologies (IDT) (Miami, FL)
- …external customers to facilitate complaint investigation process.Receive and document complaints from various sources, including customers, healthcare professionals, ... cross-functional teams, including Scientific Application Support (SAS), Quality Assurance, Regulatory Affairs, Product Development, and manufacturing to investigate and… more
- Fresenius Medical Center (Tampa, FL)
- …maintaining various departmental guidelines, procedures and templates associated with the regulatory document management system, regulatory information ... AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required to… more
- Pacificorp (Portland, OR)
- …are archived accurately in the data management system; and maintain the regulatory document center. Compile and organize information from multiple sources; ... Sr Regulatory Operations Coordinators (Portland, OR / Salt Lake...of five years of administrative experience including project and document management, or related areas. + Proficient use of… more
- Takeda Pharmaceuticals (Boston, MA)
- …book roundtables, drafting regulatory notifications, coordinating and managing regulatory document workflows, inputting information into regulatory ... to shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning - GI2 TAU...and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the… more
- University of Miami (Miami, FL)
- …include, but not be limited to: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study ... has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department...CORE JOB SUMMARY: The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting… more
- Actalent (Orlando, FL)
- …minimum of 1 year of experience in clinical research environment and regulatory document submission + Certification through professional research organizations ... Regulatory Specialist I Key Responsibilities: + Prepare and...the study team are reviewed and approved. + Maintain regulatory documents in compliance with Federal regulations, ICH/GCP guidelines,… more
- University of Miami (Miami, FL)
- …provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards, ... review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The Remote SCCC Regulatory Analyst II reviews, prepares, and provides oversight for… more
- Lilly (Indianapolis, IN)
- … team. The GRL is responsible for the creation and maintenance of the Regulatory Strategy Document (RSD) and ensures local plans, created by the regional ... the world. **Purpose:** The purpose of the Senior Director Global Regulatory Affairs, Global Regulatory Lead (GRL) role is to develop and implement innovative… more
- Takeda Pharmaceuticals (Boston, MA)
- …CTN, IND, CTA, PSP, PIP, 15-day safety notifications, and rapid response document ; Submission planning and management of Regulatory submissions: Collaborate with ... Regulatory EDMS and business development support: Provide end-user support for Regulatory electronic document management system (EDMS); Create job aids to… more
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