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Clinical Trials, Quality/Risk Management, US Regulatory Affairs
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.
Job Summary: Westat is seeking a Regulatory Affairs Operation Associate within its Clinical Trials Practice (CTP). The associate will be assigned to the Regulatory Affairs Unit (RAU) and be responsible for supporting numerous clinical trial teams that require the development and maintenance of documents associated with conducting GCP-compliant clinical trials. The associate will also be responsible for the formatting, publishing, and electronic delivery of regulated submissions to the appropriate regulatory entities.
Job Responsibilities: • Serve as the regulatory operations lead on Westat CTP project teams. • Electronically format and publish documents, build regulatory submission deliverables, and ensure quality, accuracy, and submission-readiness per regulatory agency guidance and specifications, and internal procedures. • Manage submission timelines. • Serve as the point of contact for communications with regulatory entities for technical questions regarding submissions. • Communicate regulatory system enhancement needs or technical issues. • Manage and maintain regulatory documents, including the archiving of all regulatory records. • Develop and deliver regulatory operations training workshops for CTP staff and clients. • Contribute to the development and maintenance of RAU standard operating procedures. • Contribute to regulatory operations sections on business proposal efforts, as required. • Assist in the establishment and maintenance of eTMFs as needed.
Basic Qualifications: • A High School diploma with some college course work with at least 10 plus years of regulatory operations experience related to document management and preparation of eCTD-compliant submissions is required. • Experience with preparing regulatory submissions in Common Technical Document format. • Experience with eCTD publishing systems, EDMS technology, and authoring tools and templates. • Experience with eTMF and CTMS systems.
Preferred Qualifications: • Experience with establishing and maintaining entries for regulated products in the NIH ClinicalTrials.gov database. • Practical application of DHHS regulations and guidelines, and ICH guidelines.
Candidates must have strong oral and written communication skills, organizational skills and the ability to handle multiple tasks simultaneously and work both independently and in a team environment.
Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:
Employee Stock Ownership Plan
401(k) Retirement Plan
Paid Parental Leave
Employee Assistance Program
Travel Accident Insurance
Short Term Disability Insurance
Long Term Disability Insurance
Life and AD&D Insurance
Critical Illness Insurance
Supplemental Life Insurance
Flexible Spending Account
Health Savings Account
Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.
Internal Number: 18104BR
WESTAT, located in Rockville, MD is one of the foremost contract research corporations in the United States. Since 1961, we have conducted surveys and provided statistical research and related services to the agencies of the U.S. Government and to a broad range of institutional and business clients. We are an employee-owned corporation with more than 2,000 research, technical, and administrative staff and a recognized history of technical and managerial excellence.