Regulatory Affairs Associate II

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
Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.
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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

Work arrangement
Yes