Regulatory Affairs Associate

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

This is a newly created role reporting to the Head of Quality; you will be responsible for Regulatory Affairs and Quality Assurance activities for a fast-growing company in the Complementary Medicines industry.

Your experience working as part of a team within a fast paced and deadline driven environment will see you excel in this role.

You will need highly developed attention to detail and research skills to maintain regulatory compliance of all new products.

Your key responsibilities will include:

• Developing Evidence Packages and Tables for all new products
• Managing Bulk Specifications
• Compiling Shelf-Life Justifications
• Developing and coordinating new product labels to meet all 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