- Vistra (Irving, TX)
- …other operations functions. May also interact with personnel associated with external regulatory agencies. Maintain regulatory document management system and ... **Education, Experience, and Skill Requirements** + 0-1 years experience in compliance, regulatory , project management, document management, or related areas. +… more
- MD Anderson Cancer Center (Houston, TX)
- …* Learn relevant processes for clinical trial development and IRB approval, including regulatory document maintenance. * Ensure timely submission of all required ... of the FDA approval process. * Communicate with sponsors regarding clinical trial regulatory document submissions. * Collect and develop regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …Teams, Zoom, WebEx, BlueJeans etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as eFlorence, Veeva Systems ... document tools, as well as, to provide direct regulatory /compliance guidance and facilitate investigator initiated trials and investigator-initiated multi-site… more
- Hologic (Newark, DE)
- …a hybrid schedule. **What You'll Do:** + Prepare, compile, and maintain regulatory document packages for submissions, license renewals, audits, and inspections ... improvement in compliance processes + Proficiency with MS Office and regulatory document management systems + Experience with capital equipment (preferred) +… 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
- Terumo Neuro (Aliso Viejo, CA)
- …devices are commercially available in the assigned market(s) based on the approved regulatory strategy. + Document , consolidate, and maintain verbal and written ... **12814BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval submission… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …+ Ability to work collaboratively in cross-functional teams. + Proficiency with regulatory databases, document control systems, and project management tools. ... **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding...developing and implementing practices for SaMD devices to ensure regulatory compliance, expedition of product clearances and maintain the… more
- Kelly Services (Mckinney, TX)
- …to detail. + ** Regulatory Knowledge:** Solid understanding of relevant regulatory requirements and document control processes. + **Communication & Analytical ... ** Document Control Specialist** **Food/Pharma** **McKinney, TX area** As...and maintaining all critical company documents, ensuring compliance with regulatory standards, and supporting overall quality initiatives. **Core Responsibilities:**… more
- Insight Global (Denver, CO)
- …both internal and external stakeholders, track and monitoring deliverable schedules, assist in regulatory filing document build outs and assist in building out ... Job Description Insight Global is looking for a Regulatory Project Manager in the Great Denver area....area. This individual will be responsible for oversight on regulatory filing projects. In this role you will be… more