Senior Manager, Regulatory Operations

Responsibilities

• Support the planning, coordination, tracking, and execution of global regulatory submissions and responses
• Assist regulatory and project teams in the implementation of regulatory plans and timely delivery of documentation
• Prepare regulatory submission documentation including forms and cover letters
• Support team with formatting, QC, and publishing of submission documents and packages
• Manage Veeva RIMS processes including HAI, SCP, and archiving
• Manage authoring and review workflows in Veeva RIMS according to defined timelines
• Maintain archival copies of health authority submissions, correspondence, and records of obligations
• Maintain knowledge of US and global regulations and participate in regulatory intelligence activities
• Create or contribute to SOPs, checklists, and training materials for the Regulatory department
• Support contracts and purchase orders for the Regulatory Affairs department

Requirements

• Bachelor's Degree in Life Sciences or a relevant field
• Minimum of 5 years of experience in Regulatory Affairs or Regulatory Operations
• Proficient knowledge of Veeva RIMS SCP, workflows, archival, and reporting
• Experience as a publisher (DocuBridge, GlobalSubmit, VeevaVault Submission, etc.)
• Understanding of the drug development process
• Basic knowledge of 21 CFR, FDA, ICH, GCP, GMP, eCTD, and global guidelines
• Strong proficiency in MS Word, Excel, PowerPoint, and Smartsheet
• Excellent oral and written communication skills

Preferred Qualifications

• Additional experience in the biotechnology or pharmaceutical industry
• Experience building electronic submissions in compliance with Health Authority requirements
• Experience maintaining in-house repositories for regulatory archiving in 21 CFR Part 11 compliant systems

About the Company

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development, and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders.