Regulatory Operations Associate
Technical Resources International, Inc. - Bethesda, MD
Hiring: Regulatory Operations Associate Company: Technical Resources International, Inc. Location: Bethesda, MD Job Posted Time: 2026-09-10 11:46:08 Target Skills & Keywords : Microsoft Excel, Microsoft Office About the job Required Skills: •Prepare standard documentation supporting regulatory filings and distribution to stakeholders. •Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents. •Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate. •Draft, edit, and distribute various documents as needed based on templates and work instructions. •Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc. •Track regulatory activity, maintain, and update databases, and ensure that records are complete and current. •Provide other administrative regulatory support as needed. Qualifications: •Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well. •Superior organizational skills and customer service abilities are required. •Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus. •Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects. •Operational familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable. •General knowledge of the drug and vaccine development process or clinical trials is a plus. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!