[Remote] Manager, Regulatory Operations

Note: The job is a remote job and is open to candidates in USA. Vera Therapeutics is seeking a Manager, Regulatory Operations to support its Regulatory Operations and Regulatory Affairs teams and contribute to regulatory submission activity across departments. The role focuses on preparing, formatting, publishing, reviewing, and archiving regulatory submissions in accordance with global requirements.

Responsibilities

• Assist the Regulatory Operations Lead in the preparation, publishing, and compilation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, NDA/BLA, MAA, Swissmedic, CTA, NDS)
• Work with Regulatory Operations Lead, subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions, and Submissions Archive)
• Format complex Word documents to generate compliant regulatory documents including complicated tables and graphs created in a variety of formats. Maintain the internal regulatory styles template and manage submission templates
• Maintaining the list of literature for regulatory submissions and obtaining copies of literature, as needed
• Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes
• Ensure consistency across regulatory submission documents following the regulatory style guide and formatting standards
• Support ongoing regulatory lifecycle maintenance submissions for IND and BLA applications, as needed
• Conduct final quality review of published documents and submissions to ensure consistency and compliance with regulatory requirements prior to dispatch
• Maintain and archive regulatory information management task including archiving regulatory documents, Health Authority Correspondence, submission records, and final published files within Veeva Vault RIM to ensure document traceability and completeness
• Maintain current knowledge of global regulatory submission requirements, eCTD standards, electronic submission specifications, and Health Authority requirements
• Perform other duties as assigned

Skills

• 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 (eg, Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge, eCTD Validation and viewing tools) and other formatting, publishing and QC tools (TRS Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations
• 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
• Knowledge of Accenture StartingPoint Templates is a plus

Benefits

• Eligible for an annual performance incentive bonus
• New hire equity
• Ongoing performance-based equity
• Medical, dental, and vision insurance
• 401k match
• Flexible time off
• A number of paid holidays

Company Overview

Company H1B Sponsorship