- Mount Sinai Health System (New York, NY)
- …**Electronic Binder Management:** + Assist with all aspects of clinical research regulatory compliance, including document preparation , submission and ... an opportunity to play a critical role in ensuring regulatory compliance and document management within a dynamic and fast-paced environment. The successful… more
- Actalent (Rockville, MD)
- …and international regulations, requirements and guidance associated with scientific and clinical/ regulatory document preparation and submissions + Maintain ... clinical programs. The ideal candidate will have a strong background in regulatory medical writing, particularly in completion of pending CSRs in accordance with… more
- GE Vernova (Wilmington, NC)
- …(FMEA), probabilistic risk analysis (PRA), and similar techniques. + Support nuclear regulatory certification or licensing document preparation , + Perform ... Easy5/MSC, Simulink-MATLAB/MathWorks, Mathcad/PTC, 3KeyMaster/WSC, ETAP, SKM], + Change, configuration, document and bill of material (BOM) management [e.g.; ENOVIA/Dassault-Systemes].… more
- LA Care Health Plan (Los Angeles, CA)
- …with business units in audit universe preparation and validation. Assists in document preparation for regulatory and internal audits. Regulatory ... the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance...the deficiencies. This position will be responsible for the regulatory obligations for each line of business and their… more
- Boehringer Ingelheim (Ridgefield, CT)
- …experienced CMC RA personnel, prepares cross-functional teams for FDA interactions on regulatory issues and provides guidance on preparation of briefing ... CMC and product labeling changes as well as the preparation and submission of original and/or supplemental applications and...sub teams in accordance with the CMC Functional Summary Document . + With minimal supervision, delivers US regulatory… more
- Chiesi (Cary, NC)
- …development and implementation of Chiesi Global Rare Disease procedures for the regulatory aspects of labeling preparation , launch prep, review, approval, and ... regulatory guidance documents and initiating changes in systems to ensure regulatory compliance. Knowledge of Common Technical Document and global guidelines… more
- 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
- LSI Solutions (Victor, NY)
- …will possess strong administrative skills, including proficiency in Microsoft Office, document preparation , and organizing and maintaining a master scheduling ... + All essential functions listed above. + Locate all regulatory certificates. + Independently generate document change requests as needed. + Assist in review and… more
- Kelly Services (Mukilteo, WA)
- …and QA/RA activities. - Provide support during internal and external audits and regulatory inspections. - Assist in the preparation of documents required to ... ** Document Control Coordinator** **(1-2 month project with possibility...standardize business processes and satisfy regulatory requirements. - Support other departmental personnel with administrative… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Regulatory Strategist **Location:** Morristown, NJ/Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is on to ... accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global...their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading… more