Regulatory Submissions Manager: eCTD & Vault Expert

Vera Therapeutics, Inc.; Brisbane (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Job summary

Vera Therapeutics, Inc. is seeking a Manager of Regulatory Operations to lead publishing and formatting of regulatory submissions, ensuring compliance with global requirements. The role supports cross-functional teams and uses Veeva Vault RIM for submissions management.

The position emphasizes expert Word/Adobe skills, template management, and strict quality control to maintain submission timelines and document integrity.

Qualifications

• Bachelor’s degree and 5-6 years of experience in Regulatory Operations with specialized skills in electronic submissions.
• Expert level skills in Word processing, formatting, and PDF publishing for electronic submissions.
• Experience with electronic document management and publishing systems (e.g., Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge) and tools like TRS Toolbox.
• Proficiency with MS Word and Adobe is a MUST. Knowledge of Accenture StartingPoint Templates is a plus.
• Independent work and strong communication with Regulatory Affairs.

Responsibilities

• Assist in preparation, publishing, and compilation of regulatory submission documents for IND, NDA/BLA, MAA, Swissmedic, CTA, NDS.
• Collaborate with SMEs and cross-functional teams to optimize processes using the Veeva Vault RIM suite.
• Format complex Word documents, maintain internal styles and submission templates.
• Maintain literature lists and obtain copies for submissions as needed.
• Format, edit, proof, and create bookmarks/hyperlinks per guidelines.
• Ensure consistency with regulatory style guides and formatting standards.
• Support lifecycle maintenance submissions for IND and BLA.
• Conduct final quality review prior to dispatch of documents.
• Archive regulatory information management data with traceability.

Skills

Word processing

Document formatting

PDF publishing

eCTD submissions

Veeva Vault RIM

Box

SharePoint

TRS Toolbox

Education

Bachelor's degree

Tools

MS Word

Adobe Acrobat

Lorenz DocuBridge

Job description

Vera Therapeutics, Inc. is seeking a Manager of Regulatory Operations to lead publishing and formatting of regulatory submissions, ensuring compliance with global requirements. The role supports cross-functional teams and uses Veeva Vault RIM for submissions management.

The position emphasizes expert Word/Adobe skills, template management, and strict quality control to maintain submission timelines and document integrity.