Manager, Regulatory Operations

The role

The Manager, Regulatory Operations will support submission activity by assisting with the preparation, publishing, and compilation of regulatory submission documents. This role involves Word document processing, template management, and eCTD publishing to meet global regulatory requirements.

What you will do

• Assist in the preparation, publishing, and compilation of regulatory submission documents.
• Develop processes using the Veeva Vault RIM suite.
• Format complex Word documents including tables and graphs.
• Maintain internal regulatory styles template and manage submission templates.
• Maintain the list of literature for regulatory submissions and obtain copies.
• Format, edit, proof, and create bookmarks and hyperlinks.
• Ensure consistency across regulatory submission documents.
• Support ongoing regulatory lifecycle maintenance submissions for IND and BLA applications.
• Conduct final quality review of published documents and submissions.
• Maintain and archive regulatory information management tasks within Veeva Vault RIM.

Required qualifications

• Bachelor’s degree
• 5-6 years of experience in Regulatory Operations with specialized skills in electronic submissions
• In depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions
• Relevant experience with electronic document management and publishing systems (eg, Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge, eCTD Validation and viewing tools) and other formatting, publis
• Proficiency with MS Word and Adobe is a MUST
• Committed to producing high quality and timely deliverables
• Work independently and efficiently with Regulatory Affairs
• Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills

Nice to have

• Knowledge of Accenture StartingPoint Templates is a plus

Benefits

• medical, dental, and vision insurance
• 401k match
• flexible time off
• paid holidays

About the company

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. The company was founded in 2016 and is based in Brisbane, California.