Regulatory Affairs Associate (Pharma) - Remote

Overview

The Regulatory Affairs Associate (Pharma) will manage regulatory compliance for pharmaceutical products, ensuring alignment with local and internal standards while working from home.

In Short

• Manage and maintain bulk and raw material specifications.
• Develop and coordinate product labels according to TGA standards.
• Compile Evidence Packages for product listings.
• Prepare and maintain Listed Medicine applications on ARTG.
• Ensure ongoing regulatory compliance of marketed products.
• Develop product packaging specifications.
• Conduct regulatory impact assessments.
• Communicate changes to regulatory requirements.
• Respond to regulatory queries from internal teams and customers.
• Assist with internal audits and regulatory inspections.

Requirements

• Experience in regulatory affairs within the pharmaceutical industry.
• Knowledge of TGA and other regulatory guidelines.
• Strong attention to detail and organizational skills.
• Ability to communicate effectively with stakeholders.
• Experience with product labeling and compliance documentation.

Benefits

• Work from home flexibility.
• Opportunity to contribute to pharmaceutical compliance.
• Engagement with a dynamic team.
• Professional development opportunities.