1 day ago Be among the first 25 applicants Job Title: Regulatory Affairs Specialist/Manager - 9 Months Contract W2 Job Type: Full-time Overview: We are seeking an experienced and detail-oriented Regulatory Affairs Specialist/Manager to join our team in San Diego. Key Responsibilities: Document Preparation and Quality Control: Prepare and QC regulatory documents including Clinical Trial Agreements (CTAs), investigator lists, forms, and other essential documents to ensure accuracy and compliance. SmartSheet and Veeva RIM Support: Assist with content planning, timeline management, and binders in Smartsheet . Manage and organize document workflows within Veeva RIM , ensuring seamless document management and storage. Veeva RIM Migration: Assist with the migration of regulatory documents and data to Veeva RIM , ensuring all records are transferred accurately and in compliance with regulatory requirements. Document Workflow Management: Oversee and manage document workflows within Veeva RIM , ensuring timely processing, approval, and archival of regulatory documents. Site Activation & Drug Shipment Support: Assist with the review of essential documents for site activation and coordination of drug shipments, ensuring timely and accurate completion. Clinical Trial Transparency Activities: Support the clinical trial transparency activities, including regulatory filings on ClinicalTrials.gov and other platforms, ensuring transparency and compliance with relevant regulations. Qualifications: Experience: 5+ years of experience in Regulatory Affairs or a related field, preferably in the pharmaceutical, biotech, or clinical research industry. Technical Skills: Proficiency with Veeva RIM , Smartsheet , SharePoint , MS Office Suite , and ClinicalTrials.gov . Knowledge: Strong understanding of regulatory documentation, workflows, and compliance requirements in clinical trials and drug development. Organizational Skills: Ability to manage multiple tasks and prioritize deadlines effectively. Communication: Strong written and verbal communication skills to interact with internal teams and external stakeholders. Education: A bachelor’s degree in Life Sciences, Regulatory Affairs, or a related field is preferred. Additional Information: This position is based in San Diego and requires being in the office 3 days per week. Remote work options are available for the remaining days. Seniority level Associate Employment type Contract Job function Science, Writing/Editing, and Research Industries Pharmaceutical Manufacturing, Staffing and Recruiting, and Biotechnology Research #J-18808-Ljbffr Meet
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