Job description
Regulatory Affairs Associate II W2 Contract Pay Rate $50 - $54 per hour Location Remote Role - CA PST Job Summary The Regulatory Affairs Associate II Contractor supports regulatory activities across development programs, with a focus on regulatory operations, document management, and contribution to regulatory strategy for assigned projects. This role is responsible for tracking regulatory deliverables, maintaining regulatory document repositories, and supporting submission readiness and lifecycle management activities under direct supervision. Duties and Responsibilities • Track regulatory deliverables, milestones, and timelines across development programs to ensure visibility and timely completion. • Maintain regulatory document repositories and archives (e.g., Veeva RIM, Veeva eTMF), including version control and document accuracy. • Perform detailed document quality control (QC) checks to ensure formatting, completeness, and compliance with FDA eCTD requirements and internal SOPs. • Support regulatory publishing activities, including document compilation, formatting, hyperlinking, and bookmarking under guidance. • Coordinate with cross-functional partners (CMC, Clinical, Quality) to collect, organize, and manage submission deliverables. • Assist in preparing and maintaining submission trackers, document inventories, and regulatory correspondence logs. • Support post-submission activities, including filing regulatory correspondence and tracking agency questions and responses • Contribute to the ongoing maintenance and improvement of Regulatory Operations processes, templates, and SOPs. • Support inspection and audit readiness by ensuring regulatory records are complete, organized, and readily retrievable • Assist with the transfer of regulatory documents to external partners as required. • Conduct periodic eTMF reviews for Regulatory and Safety documentation. Requirements and Qualifications • Bachelor's degree in Life Sciences, Regulatory Affairs, or a related field, plus 2+ years of experience in regulatory affairs or an equivalent role • Proficiency in Microsoft Word and Excel, and Adobe Acrobat for document preparation and review • Strong organizational skills with exceptional attention to detail and accuracy • Ability to manage multiple deliverables and meet deadlines in a fast-paced environment • Clear, professional written and verbal communication skills • Experience with Smartsheet, Veeva RIM, and Veeva eTMF preferred Desired Skills and Experience Regulatory affairs, regulatory operations, regulatory submissions, FDA eCTD requirements, submission publishing, document QC and version control, Veeva RIM, Veeva eTMF, regulatory document management, submission and milestone tracking, agency correspondence, inspection and audit readiness, SOP compliance, cross-functional coordination, Smartsheet, Microsoft Word and Excel, Adobe Acrobat, 2+ years of regulatory affairs experience Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate. Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.
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