- Takeda Pharmaceuticals (Boston, MA)
- …managing regulatory document workflows, inputting information into regulatory information management systems, preparing, checking and tracking ... Significant experience in global drug development regulations, regulatory submissions, lifecycle management , compliance, business systems technology… more
- Parexel (St. Paul, MN)
- …practice Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency ... lead the development of appropriate responses. Participate in Safety Management Team (SMT) and Global Regulatory Team...manage the review and approval of labeling in a document management system. Electronic document … more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS). Competencies See OPDC Competencies Chart ... strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment… more
- Boehringer Ingelheim (Ridgefield, CT)
- …pathways. Define US strategic considerations in the generation of a Global Regulatory Strategy Document . In cooperation with US/Global Labeling, provide ... all local and global project related documentation such as management summaries, TALC / HPSC / DC pre-reads, are...regulatory trends and developments for their impact on drug development activities and on existing development strategies. Share… more
- Lilly (Durham, NC)
- …and OUS: Includes networking with Supply chain, Global Quality Leaders, Senior Management , Legal, Regulatory , Global Patient Safety, Qualified Persons at ... to those who need them, improve the understanding and management of disease, and give back to our communities...is responsible for providing GMP/GxP support across the different regulatory reporting and inspection support that is provided by… more
- Bank of America (Charlotte, NC)
- …Trend Analysis Financial Accounting Interpret Relevant Laws, Rules, and Regulations Regulatory Compliance Risk Management Attention to Detail Continuous ... Improvement Financial Analysis Project Management Reporting Analytical Thinking Oral Communications Regulatory ...the dangers and resulting consequences of illegal and illicit drug use and alcohol abuse. Our Drug -Free… more
- Wells Fargo (Charlotte, NC)
- …of CRE lending bilateral and/or syndicated focusing on loan documentation and deal management . In this role, you will: Prepare, negotiate and track various legal ... transactions with bank counterparties. Work on various projects as requested by management . Interpret policy when working with legal, credit and the relevant… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …annual budget, and manage spend. Author and conduct periodic review of regulatory intelligence management Standard Operating Procedures or work practices. Review ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...technology platform. Lead internal process to obtain, coordinate, and document cross-functional SME impact assessments of new or updated… more
- Teva Pharmaceuticals (West Chester, PA)
- …to inquiries from regulatory agencies. Assist in implementation of electronic document management system in the department. Plan and oversee the compilation ... Associate Director, Regulatory Affairs Date: Dec 2, 2025 Location West...to assigned products. Support maintenance activities for investigational new drug applications (INDs), new drug applications (NDAs)… more
- Sumitomo Pharma (Frankfort, KY)
- …will be responsible for leading development of all non-clinical and clinical regulatory strategies including management of IND and NDA submissions, FDA ... regulatory affairs activities; provide relevant input to Leadership Oversee the regulatory activities at CROs, providing document review in order to ensure… more
- ICON Clinical Research (Raleigh, NC)
- …treatments and therapies. What you will be doing: Participate in provision of regulatory expertise in strategic drug development across multiple areas. Take part ... experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical… more
- GE HealthCare (Chicago, IL)
- …Work is subject to GE HealthCare policy objectives. Regularly advises Quality and Regulatory management in business development. Has a supportive role in ... and regulatory expectations. Standardization of processes, tools, and performance management system. Requires ability to lead functional teams or projects with… more
- Eisai, Inc (Bethesda, OH)
- …and data standards (eg, CDISC).Extensive experience with Regulatory Information Management (RIM) systems and Document Management Systems (eg, ... MarketsAdvance experience with the drug development process and eCTD regulatory submission standardsExpert understanding of Project Management concepts and… more
- Capital One (Richmond, VA)
- …control environment. Expected VRA Deliverables and Results Immediate deliverable: build and document the HR Risk Management Framework across the expanding global ... HR teams, Legal and Compliance to review and update regulatory applicability HR Controls: identify and document ...Controls: identify and document appropriate controls and document in the Risk Management system of… more
- AbbVie (North Chicago, IL)
- …Chain, Trade Compliance and Procurement. Responsibilities Using a collection of program management tools, independently define and document the program scope, ... . Job Description The ME&C Associate Director is a global program management expert responsible for managing major global programs and projects across disciplines… more
- Stony Brook University (Stony Brook, NY)
- …a minimum of three (3) professional references. Successfully complete a 4 panel drug screen Meet Regulatory Requirements for pre employment screenings. Provide a ... Office Assistant 1 - Health Information Management Full Time Day Shift (7:30 AM -...calculations; mail, supply, and inventory functions; keyboarding and other document preparation tasks; answering telephones; completing forms; assisting customers;… more
- Eisai, Inc (Nutley, NJ)
- …for all of Eisai's products.Maintain centralized labeling repository within Eisai's electronic document management system for all global labels at various stages ... for the leadership and oversight of the Labeling function within Global Regulatory Services and Operations (GRSO). This position will manage labeling operations and… more
- Bank of America (Boston, MA)
- Identity and Access management (IAM) Mainframe Security Administration Sr Manager (RACF exp. required) Boston, Massachusetts;Washington, District of Columbia To ... be at least 18 years of age. Acknowledge (https://ghr.wd1.myworkdayjobs.com/Lateral-US/job/Boston/Identity-and-Access- management --IAM--Mainframe-Security-Administration-Sr-Manager--RACF-exp-required-_25045363-2) Job Description: At Bank of America, we… more
- Bank of America (New York, NY)
- …Serve as executive sponsor for key acquisition initiatives, ensuring strong governance, regulatory compliance, and risk management . Manage and oversee referral ... Strategic Referral Management Executive New York, New York;Boston, Massachusetts To proceed with your application, you must be at least 18 years of age. Acknowledge… more
- MetLife (New York, NY)
- …a robust oversight framework and drive continuous improvement in AI risk management . How You'll Help Us Build a Confident Future (Key Responsibilities) Monitoring ... with risk tiering and control partner expectations. Control Tracking: Track and document the execution of medium and high-risk controls, ensuring mitigation plans… more
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