Manager, Regulatory Operations

🕒 October 19

🏄 California – Remote

🏄 California – Remote

💵 $120k - $170k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• Support cross-functional departments with regulatory submission activity • Assist in preparing, publishing, and compiling regulatory submission documents for IND, NDA/BLA, MAA, Swissmedic, CTA, and NDS applications • Analyze and develop processes supporting business needs using the Veeva Vault RIM suite • Format complex Word documents, including tables and graphs, and maintain regulatory style and submission templates • Maintain literature lists and obtain literature copies for regulatory submissions • Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes • Ensure consistency across regulatory submission documents • Support regulatory lifecycle maintenance submissions for IND and BLA applications • Conduct final quality reviews of published documents and submissions before dispatch • Maintain and archive regulatory information, Health Authority correspondence, submission records, and final published files in Veeva Vault RIM • Maintain current knowledge of global regulatory submission requirements, eCTD standards, electronic submission specifications, and Health Authority requirements • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree and 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, including Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge, eCTD Validation and viewing tools, and TRS Toolbox • Experience with global regulatory submissions or other experience directly related to Regulatory Operations • Proficiency with MS Word and Adobe is a MUST • Knowledge of Accenture StartingPoint Templates is a plus • Committed to producing high quality and timely deliverables • Ability to work independently and efficiently with Regulatory Affairs • Flexibility, patience, and good verbal, written, and interpersonal communication skills

🏖️ Benefits

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401(k) match • Flexible time off • Paid holidays

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