Regulatory Affairs Associate II

Bayside Solutions; California; On-site; USD 90,000 - 120,000; Full time

Job summary

Bayside Solutions, Inc. seeks a Regulatory Affairs Associate II Contractor to support regulatory operations across development programs, focusing on document management and strategy contributions under supervision.

Responsibilities include tracking deliverables, maintaining Veeva RIM/eTMF docs, QC for FDA eCTD, and aiding submission readiness. Requires 2+ years in regulatory affairs, MS Office, and preferred Veeva experience. Bayside reserves W2 eligibility and sponsorship limitations.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs, or related field.
• 2+ years of experience in regulatory affairs or equivalent role.
• Proficiency with Word, Excel, and Adobe Acrobat for document prep and review.
• Strong organizational skills and attention to detail with deadlines.
• Experience with Smartsheet, Veeva RIM, and Veeva eTMF preferred.

Responsibilities

• Track regulatory deliverables, milestones, and timelines across programs.
• Maintain regulatory document repositories and archives (Veeva RIM/eTMF).
• Perform QC checks for FDA eCTD formatting and completeness.
• Support submission readiness and regulatory publishing under guidance.
• Coordinate with CMC, Clinical, Quality to collect and manage deliverables.
• Prepare submission trackers, document inventories, and logs.
• Support post-submission activities and inspection readiness.

Skills

Word

Excel

Adobe Acrobat

Documentation control

Attention to detail

Multitasking

Written communication

Verbal communication

Regulatory submissions

Smartsheet

Veeva RIM

Veeva eTMF

Education

Bachelors in Life Sciences / Regulatory Affairs

Tools

Veeva RIM

Veeva eTMF

Smartsheet

Job description

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.