Regulatory Operations Associate II: Submissions & Document Management

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

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.