Manager, Regulatory Operations

Position Summary:

The Manager, Regulatory Operations will be a key contributor to Vera Therapeutics’ Regulatory Operations and Regulatory Affairs teams, reporting to the Associate Director, Regulatory Operations and Publishing. Primary responsibilities include Word document processing/formatting, template development and management, PDF publishing and review, eCTD publishing, review, and archiving consistent with global regulatory requirements for different application types.

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 (e.g., IND, NDA/BLA, MAA, Swissmedic, CTA, NDS).
• Collaborate 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 various formats. Maintain the internal regulatory styles template and manage submission templates.
• Maintain the list of literature for regulatory submissions and obtain 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 tasks, 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.