- Gilead Sciences, Inc. (Foster City, CA)
- …**You Will Need:** + An understanding of the drug development process and regulatory document landscape. + Experience with clinical regulatory documents ... and PowerBI), as well as Adobe Acrobat, SharePoint, Smartsheet, and a regulatory document management system such as Veeva. **U.S. Education & Experience** +… 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
- University of Pennsylvania (Philadelphia, PA)
- …Microsoft Teams, Zoom, WebEx, etc. Knowledge and/or experience working with web-based e- regulatory document management systems such as Veeva Systems products, ... programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist C Job Profile Title Clinical Research...the Electronic Common Technical Document (eCTD), etc. is a plus. Resume and cover… more
- Dana-Farber Cancer Institute (Boston, MA)
- …group. In coordination with the ROM, implements systems to monitor and ensure regulatory document collection and to maintain compliance and audit-ready state. ... The Assistant Regulatory Operations Manager (AROM) is a newly created...for aiding in oversight of the Leukemia disease group's regulatory research portfolio. This position involves close collaboration with… more
- Takeda Pharmaceuticals (Columbus, OH)
- …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
- University of Miami (Miami, FL)
- …and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance + Serves as point of contact for various ... University of Miami has an exciting opportunity for a Regulatory Analyst with Bascom Palmer Eye Institute in the...Palmer Eye Institute in the Department of Research. The Regulatory Analyst will be responsible for conducting the on-site… 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
- Sumitomo Pharma (Columbus, OH)
- …strategies and the ability to contribute to the development and writing of a regulatory strategy document + Ability to learn new therapeutic areas when necessary ... a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory … more
- Sumitomo Pharma (Columbus, OH)
- …and the ability to contribute to the development and writing of a regulatory strategy document in coordination with clinical plans and marketing objectives ... and experienced individual for the position of **Associate Director, Regulatory Affairs** . The Associate Director is part of...as deemed appropriate by the GRL, may be the document owner of briefing books to Health Authorities +… more
- Merck (North Wales, PA)
- …mitigation measures. + Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity. + Lead ... for developing and implementing Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for our organization's biologics product franchises in accordance… more
- MicroVention, Inc. (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 ... **12271BR** **Title:** Sr. Specialist, Regulatory Affairs **Job Description:** Responsible for preparing strategy for worldwide product approval timeline, submission… more
- Lundbeck (Deerfield, IL)
- …+ High proficiency in MS Word, MS Excel and Adobe Acrobat and regulatory electronic document management systems + The Company requires all employees ... Senior Manager Regulatory Strategy - Remote Opportunity Requisition ID: 5804...Preferably East Coast or Midwest.** **SUMMARY:** The Senior Manager, Regulatory Strategy (US RA): supports the creation and implementation… more
- System One (Florham Park, NJ)
- …and regulations. The scope of this role includes formatting and publishing regulatory documents, managing document tracking and version control, archiving on- ... Senior Regulatory Operations Associate Contractor (Publishing) Must be local...will bring project management skills and technical experience in document management and publishing systems to this role. Responsibilities… more
- Tutor Perini (Mount Pleasant, NY)
- …and retrieved in compliance with the Contract requirements, company policies, and regulatory requirements. The Document Control Specialist is critical in ... ** Document Control Specialist** Office or Project Location **Mt....Code **2536** Frontier-Kemper, a Tutor Perini Company, is seekinga ** Document Control Specialist** to join our Kensico-Eastview Connection Tunnel… more
- S&P Global (New York, NY)
- …that span client reference data collection and management, client lifecycle management, regulatory compliance, and document management. + ** Regulatory ... internal use):** 12 **_The_** **_Role:_** **_Regional Commercial Associate Director - Regulatory Compliance_** **The Team:** This commercial position is part of S&P… more
- Huntington National Bank (Columbus, OH)
- …recommendations intended to enhance risk management practices and the accuracy of the regulatory reporting process. + Document results of testing in consistent ... As part of Huntington's Corporate Risk Management organization, the Liquidity Risk Regulatory Reporting Analyst will perform on-going testing and assessments of the… more
- ICU Medical (Lake Forest, IL)
- …requirements and be proactive in maintaining compliance . Prepare and review Regulatory Assessments; formally document the rationale for circumstances which ... *Position Summary* The Regulatory Affairs Associate will assist with 510(k) submissions,International Licensing and Submissions, and respond to routine regulatory… more
- ICF (Los Angeles, CA)
- …tariffs to inform design of programs and pricing strategies. + Observe and document regulatory proceedings, participate in forums that inform utility planning ... Description **Senior Regulatory Advisor - California Energy and Decarbonization** **Location:**...Angeles office) **Ready to make a difference?** As the Regulatory Manager you will be responsible for actively engaging… more
- Vera Therapeutics (Brisbane, CA)
- … and clinical document production. * Support clinical and regulatory document preparation (eg, eCTD modules, briefing documents, study protocols, ... clear, accurate, and effective presentation of analyses and messaging. * Manage document timelines, ensuring alignment with overall regulatory and program… more