Regulatory & QA Specialist: New Products & Compliance

CMG Holdings Group; Sydney; On-site; AUD 90,000 - 140,000; Full time

Job summary

CMG Holdings Group in Sydney is seeking a Regulatory Affairs and Quality Assurance professional to lead compliance activities for a fast-growing Complementary Medicines company. You will develop evidence packages, manage product specs, shelf-life justifications, and coordinate new labels to meet TGO92 & TGO116, while reviewing ARTG listings and overseeing change control and stability programs.

This role requires meticulous attention to detail, strong research skills, and the ability to work

Qualifications

• Experience in Regulatory Affairs and Quality Assurance for new products.
• Strong attention to detail and research skills to ensure regulatory compliance.
• Ability to work in a fast-paced, deadline-driven team environment.

Responsibilities

• Developing Evidence Packages and Tables for all new products
• Managing Bulk Specifications
• Compiling Shelf-Life Justifications
• Developing and coordinating new product labels to meet regulatory requirements such as TGO92 & 116
• Reviewing and submitting Listed Medicines on the ARTG
• Maintaining regulatory compliance of all products
• Managing Change Control for new products
• Managing all Product Stability activities

Job description

CMG Holdings Group in Sydney is seeking a Regulatory Affairs and Quality Assurance professional to lead compliance activities for a fast-growing Complementary Medicines company. You will develop evidence packages, manage product specs, shelf-life justifications, and coordinate new labels to meet TGO92 & TGO116, while reviewing ARTG listings and overseeing change control and stability programs.

This role requires meticulous attention to detail, strong research skills, and the ability to work