Manager, Regulatory Operations

Responsibilities

• Assist the Regulatory Operations Lead in preparing, publishing and compiling regulatory submissions
• Develop processes using the Veeva Vault RIM suite
• Format complex Word documents, tables and graphs; maintain regulatory style templates
• Maintain literature lists for regulatory submissions
• Conduct final quality review of published documents before dispatch
• Archive regulatory documents and submission records within Veeva Vault RIM
• Maintain current knowledge of global eCTD and Health Authority requirements

Requirements

• Bachelor's degree and 5-6 years in Regulatory Operations
• Expert Word processing, formatting and PDF publishing for electronic submissions
• Experience with electronic document management and publishing systems
• Proficiency with MS Word and Adobe
• High-quality, timely deliverables
• Strong verbal, written and interpersonal communication

Preferred Qualifications

• Knowledge of Accenture StartingPoint Templates

Benefits

• Annual performance incentive bonus and equity
• 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 autoimmune disease, starting with the kidney.