What are the responsibilities and job description for the Regulatory Affairs Manager position at Meet?
1 day ago Be among the first 25 applicantsJob Title : Regulatory Affairs Specialist / Manager - 9 Months Contract W2Job Type : Full-timeOverview : 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 AssociateEmployment type ContractJob function Science, Writing / Editing, and ResearchIndustries Pharmaceutical Manufacturing, Staffing and Recruiting, and Biotechnology Research#J-18808-Ljbffr
