Regulatory Operations Specialist - Submissions & Compliance

Nurix Therapeutics; City of Brisbane; On-site; AUD 140,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company in Brisbane is seeking a Senior Associate in Regulatory Operations. This role involves coordinating and supporting regulatory submissions and ensuring compliance with health authority regulations. The ideal candidate should have 4-5 years of experience in Regulatory Affairs, working knowledge of Veeva RIMS, and excellent communication skills. The position offers a salary range of $140K – $160K plus bonus and equity.

Qualifications

• Minimum of 4-5 years' experience in Regulatory Affairs or Regulatory Operations.
• Understanding of the drug development process.
• Basic knowledge of 21 CFR, FDA, ICH, GCP, GMP, eCTD, and global guidelines.
• Ability to take ownership of assignments and consult team members.

Responsibilities

• Support planning and tracking for regulatory submissions.
• Assist in implementing regulatory plans and timely delivery.
• Prepare regulatory submission documentation.
• Manage Veeva RIMS processes and document workflows.
• Communicate project decisions to Regulatory leadership.

Skills

Regulatory Affairs

Regulatory Operations

Veeva RIMS

Communication skills

Time management

Education

Bachelor's Degree in Life Sciences

Tools

Veeva RIMS

DocuBridge

GlobalSubmit

VeevaVault

Job description

A leading biopharmaceutical company in Brisbane is seeking a Senior Associate in Regulatory Operations. This role involves coordinating and supporting regulatory submissions and ensuring compliance with health authority regulations. The ideal candidate should have 4-5 years of experience in Regulatory Affairs, working knowledge of Veeva RIMS, and excellent communication skills. The position offers a salary range of $140K – $160K plus bonus and equity.