Regulatory Submissions Manager — Publishing & Documentation

Vera Therapeutics, Inc.; Oregon; Hybrid; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Vera Therapeutics, Inc. is seeking a Manager, Regulatory Operations to join the Regulatory Operations and Publishing teams in California. You will support submission activities, formatting, template development, PDF publishing, and eCTD processes.

You will work with cross-functional teams to prepare IND/NDA/BLA submissions, maintain submission templates, and ensure regulatory style guide compliance across documents. Proficiency in MS Word, Adobe, and Veeva Vault RIM is essential.

Qualifications

• Bachelor's degree and 5-6 years of Regulatory Operations experience.
• Expert Word processing, formatting, and PDF publishing for submissions.
• Experience with electronic document management and publishing systems (Veeva Vault RIM, Box, SharePoint).
• Proficiency with MS Word and Adobe.
• Independent worker with strong communication and timing skills.
• Flexible and detail oriented in a regulatory context.

Responsibilities

• Prepare, publish, and compile regulatory submission documents for various applications (IND, NDA/BLA, MAA, CTA, NDS).
• Collaborate with regulatory and cross-functional teams to improve processes using Veeva Vault RIM.
• Format complex Word docs with tables/graphs; maintain submission templates and styles.
• Manage literature lists and obtain copies as required for submissions.
• Create bookmarks/hyperlinks and ensure consistency with style guides.
• Support lifecycle maintenance for IND and BLA submissions as needed.
• Conduct final quality review of published documents prior to dispatch.
• Archive regulatory information management files for traceability.

Skills

MS Word

Adobe Acrobat

Word processing

PDF publishing

Veeva Vault RIM

eCTD submissions

Regulatory Ops

Education

Bachelor's degree

Tools

Veeva Vault RIM

Box

SharePoint

Lorenz DocuBridge

eCTD Tools

Job description

Vera Therapeutics, Inc. is seeking a Manager, Regulatory Operations to join the Regulatory Operations and Publishing teams in California. You will support submission activities, formatting, template development, PDF publishing, and eCTD processes.

You will work with cross-functional teams to prepare IND/NDA/BLA submissions, maintain submission templates, and ensure regulatory style guide compliance across documents. Proficiency in MS Word, Adobe, and Veeva Vault RIM is essential.