- Butterball (Mulberry, AR)
- …targeted levels of the customer product specifications. Ensures food safety, regulatory and company compliance, and compliance with all established safety ... appropriate.. Assists with facility, customer, and third-party audits and audit preparation . Responsible for daily SOP audits.. Participates in investigation of… more
- AbbVie (San Francisco, CA)
- …regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation Qualifications Qualifications + A ... Purpose The medical writer is responsible for providing clinical regulatory document support to clinical teams, ensuring successful preparation of high… more
- University of Rochester (Rochester, NY)
- …Responsible for all aspects of clinical trial start-up oversight including protocol review, regulatory document preparation , and consent form preparation ... and submission to IRB. + Ensures maintenance of all human based study's regulatory records and subject study files. Oversees and participates in internal research… 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 ... Appeals & Grievances Regulatory Audit Readiness Specialist II Job Category: Customer...the guidelines and protocols to ensure readiness for all regulatory audits. This position will develop, with the assistance… more
- University of Florida (Gainesville, FL)
- …to University policy or for the contracted length of time, whichever is longer. Regulatory document preparation and review Regulatory Binder and/or ... be annually updated for members of the study team Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations… more
- Stanford University (Stanford, CA)
- …to highly competitive graduate and medical school positions. Duties Include: * Assist in regulatory document preparation for study * Assist with the ... * Contribute to publication of findings as needed. Participate in the preparation of written documents, including procedures, presentations, and proposals. * Help… 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
- Legrand NA (Canonsburg, PA)
- …documentation, including procedures, manuals, records, and technical reports. + Regulatory Compliance Leadership:Ensure all document control practices comply ... and deliver advanced training programs for staff and stakeholders on document control policies, systems, and regulatory updates. Benefit Highlights:… more
- Actalent (Hunt Valley, MD)
- Job Title: QA Associate I, Document ControlJob Description The QA Associate I, Document Control ensures compliance with cGMP and internal policies, procedures, ... area. These may include quality operational tasks, product release, process quality, document control, quality systems or operations, or compliance. + Support or… more
- Austal USA (Mobile, AL)
- REPORTS TO: Document Control Coordinator SUPERVISES: None AUTHORITIES / RESPONSIBILITIES: Serves as the resident technical expert for Document Control; ... + Responsible for issuing, receiving and tracking drawings to Production, Client and Regulatory Body + Control and issue of all engineering change paper +… more
- AECOM (Sacramento, CA)
- …external regulatory requirements. **JOB RESPONSIBILITIES:** + Maintain and enforce document control processes from ** document creation to final archiving** . ... (eg, ISO 9001, project specs). + Ensure best practices are applied for preparation and maintenance of document registers, metadata reports, and compliance logs.… 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… 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
- Sanofi Group (Morristown, NJ)
- …experience (regionally and/or global) + Significant track record of US regulatory expertise required (demonstrated experience with preparation of BLA/NDA, ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...team members. This includes the authoring of the briefing document focused on the strategy and scientific content, and… more
- Fifth Third Bank, NA (Cincinnati, OH)
- …+ Make copies, ensure required documents are included, etc. + Responsible for preparation , quality check and delivery of regulatory file submissions in ... AND RESPONSIBILITIES: + Attend audit meetings and execute on document requests from staff and LOB owners. + Work...+ Organize and maintain file components associated with a regulatory audit. This may include, but not exclusive to,… more
- Sanofi Group (Morristown, NJ)
- …biologics products + Demonstrated significant leadership experience with driving the preparation of regulatory documents (eg (s)BLA/(s)NDA/ MAA, INDs/CTAs, ... organizing + Demonstrated experience working in and strong knowledge of electronic document management systems to obtain and leverage regulatory deliverables (eg… more
- Endo International (Rochester, MI)
- …we serve live their best life. **Job Description Summary** The Manager, Preparation Services, is responsible for operations utilizing hourly union operators that ... contract. Responsible for oversight of group leaders and supervisors in Preparation Services. Ensures compliance with documentation reviews, training, and change… more
- Otsuka America Pharmaceutical Inc. (Columbus, OH)
- …working in the pharmaceutical and/or healthcare industry. - Knowledge and experience with preparation of global regulatory submissions (IND, CTA, NDA or BLA, ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more
- Sanofi Group (Morristown, NJ)
- …and/or global). + Significant track record of US, EU and International regulatory expertise required (demonstrated experience with preparation of NMAs, LCM ... **Job Title:** Regulatory Strategist - Vaccines **Location** : Swiftwater, PA/...+ May lead the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Regulatory Strategist **Location** : Cambridge, MA/Morristown, NJ **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
