About the job

𝗥𝗘𝗚𝗨𝗟𝗔𝗧𝗢𝗥𝗬 𝗔𝗙𝗙𝗔𝗜𝗥𝗦 & 𝗤𝗨𝗔𝗟𝗜𝗧𝗬 𝗠𝗔𝗡𝗔𝗚𝗘𝗥

AgeMate is an Australian founded company in the longevity space, marketing a fast growing, subscription based supplement product across multiple global markets.

We are seeking a full time Regulatory Affairs & Quality Manager, Melbourne based, to join our team.This role offers hybrid work flexibility of 3 days in the office and 2 days from home.We are a growing team of almost 20, headquartered in Cremorne, Melbourne.

𝗦𝗮𝗹𝗮𝗿𝘆: $𝟭𝟮𝟬,𝟬𝟬𝟬–$𝟭𝟰𝟬,𝟬𝟬𝟬 𝗯𝗮𝘀𝗲 + 𝘀𝘂𝗽𝗲𝗿𝗮𝗻𝗻𝘂𝗮𝘁𝗶𝗼𝗻, depending on experience.

𝗧𝗛𝗘 𝗥𝗢𝗟𝗘

As a Regulatory Affairs & Quality Manager at AgeMate, you will play a critical role in ensuring the safety, quality, and regulatory compliance of our products supplied in Australia.

The core focus of the role is Quality and Pharmacovigilance, while also supporting the broader regulatory affairs requirements of our TGA listed complementary medicines.

You will own and operate the company’s pharmacovigilance and post market surveillance processes and will be nominated as AgeMate’s Australian Pharmacovigilance Contact Person (A-PVCP / QPPV), ensuring adverse events, product complaints, and safety signals are appropriately monitored, investigated, and reported in line with Therapeutic Goods Administration (TGA) requirements.

You will also support the company’s quality oversight framework, working closely with Supply Chain, Product, Customer Service, and contract manufacturers to ensure our products consistently meet high quality standards.

From a regulatory affairs perspective, you will support the ongoing compliance of our TGA listed complementary medicines, including ARTG listings, formulations, ingredients, product labels, claims, evidence requirements, and broader Sponsor obligations.

This is a hands on role with significant ownership across Quality, Pharmacovigilance, and Regulatory Affairs, and is suited to someone with experience working with TGA regulated complementary medicines who is comfortable taking ownership in a growing business.

𝗔𝗕𝗢𝗨𝗧 𝗬𝗢𝗨

You care deeply about product quality and consumer safety and have experience ensuring both are maintained within a regulated environment.

You have worked with TGA listed complementary medicines and have experience across Quality, Regulatory Affairs, Pharmacovigilance, or a combination of these areas.

You understand the regulatory framework surrounding complementary medicines and are comfortable working across product compliance, complaints, post market monitoring, and quality processes.

Previous hands on pharmacovigilance experience is highly regarded; however, we are also open to strong Regulatory Affairs and Quality candidates who are comfortable developing further capability in this area and taking responsibility as AgeMate’s A-PVCP / QPPV. External specialist Pharmacovigilance support is available where required.

You are structured and detail oriented, with a strong ability to investigate issues, manage documentation, and ensure regulatory requirements are consistently met.

You are pragmatic and solutions focused, able to work cross functionally to resolve issues and improve systems without over engineering processes.

𝗖𝗢𝗥𝗘 𝗥𝗘𝗦𝗣𝗢𝗡𝗦𝗜𝗕𝗜𝗟𝗜𝗧𝗜𝗘𝗦

𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝘃𝗶𝗴𝗶𝗹𝗮𝗻𝗰𝗲 𝗮𝗻𝗱 𝗦𝗮𝗳𝗲𝘁𝘆 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴• Act as AgeMate’s nominated Australian Pharmacovigilance Contact Person (A-PVCP / QPPV) for its ARTG listed complementary medicines• Maintain the company’s Adverse Event Reporting System and Adverse Event Register• Assess and document adverse events and support reporting to the TGA within required regulatory timeframes• Coordinate follow up and investigation of adverse events where required• Monitor adverse event trends and identify potential safety signals• Work with Customer Service to ensure potential adverse events are appropriately identified and escalated• Work with external Pharmacovigilance specialists where additional support is required

𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗖𝗼𝗺𝗽𝗹𝗮𝗶𝗻𝘁𝘀 𝗮𝗻𝗱 𝗣𝗼𝘀𝘁 𝗠𝗮𝗿𝗸𝗲𝘁 𝗦𝘂𝗿𝘃𝗲𝗶𝗹𝗹𝗮𝗻𝗰𝗲• Maintain the Product Complaint Register• Investigate product complaints and determine whether issues represent safety concerns or quality defects• Monitor complaint and safety trends and escalate issues where required• Coordinate investigations and corrective actions where appropriate• Support the company in maintaining effective post market surveillance processes

𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗢𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁• Manage internal product quality review processes• Coordinate blind tasting panels and sensory evaluations where applicable• Maintain the company’s retained sample program for finished product batches• Coordinate independent third party laboratory testing to verify product quality and label claims• Investigate unexpected or out of specification testing results• Maintain appropriate quality documentation and records

𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗢𝘃𝗲𝗿𝘀𝗶𝗴𝗵𝘁• Support quality oversight of contract manufacturers and suppliers• Maintain Quality Agreements with contract manufacturers where applicable• Review Certificates of Analysis (COAs) where required• Support investigation of manufacturing issues affecting product quality• Maintain finished product specifications and relevant quality documentation• Support supplier qualification and quality monitoring

• 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗔𝗳𝗳𝗮𝗶𝗿𝘀 & 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲• Support ongoing compliance of products listed on the Australian Register of Therapeutic Goods (ARTG)• Support ARTG listings and regulatory requirements associated with new products and product changes• Review product formulations and ingredients for compliance with TGA complementary medicines requirements• Maintain evidence files supporting product claims• Review product labels, packaging, and claims for regulatory compliance• Monitor ingredient compliance with the Permissible Ingredients Determination• Monitor regulatory developments impacting AgeMate products• Support the company in meeting its obligations as Sponsor of therapeutic goods in Australia