Regulatory Affairs & Quality Manager (Melbourne)

Regulatory Affairs & Quality Manager (Melbourne)

14 Sep
|
AgeMate
|
Melbourne

14 Sep

AgeMate

Melbourne

AgeMate is an Australian founded company in the longevity space, marketing a rapid 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.
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.
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.
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
Maintain the Product Complaint Register
Investigate product complaints and determine whether issues represent safety concerns or quality defects
Monitor complaint and safety trends and elevate issues where required
Coordinate investigations and corrective actions where appropriate
Support the company in maintaining effective post market surveillance processes
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
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
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
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
This role requires experience working within TGA regulated complementary medicines or a closely related therapeutic goods environment.
Proven experience working with TGA listed complementary medicines or therapeutic goods
Experience across Quality Assurance, Regulatory Affairs, Pharmacovigilance, or a combination of these areas
Strong understanding of TGA requirements and Sponsor obligations for listed complementary medicines
Experience with product formulations, ingredients, labels, claims, or regulatory documentation
Experience investigating product complaints, safety issues, and quality deviations
Experience working with complementary medicine contract manufacturers or suppliers
Experience with pharmacovigilance, adverse event management, or post market surveillance is highly regarded
Previous experience as an A-PVCP / QPPV is highly regarded but not essential
Strong attention to detail and documentation discipline
Structured approach to investigations and root cause analysis
Strong understanding of regulatory compliance and risk assessment
Ability to manage safety and quality data in a clear and organised manner
Strong communication skills when working with cross functional teams
Pragmatic and solutions focused approach
Ability to operate independently and take ownership
Ability to operate effectively in a growing, fast moving environment
Applicants must have full working rights in Australia.
Applicants must be based in Victoria.
Application Review
45 Minute Video Interview
Case Study
Personality Psychometric Assessment
Formal Offer and Contract Negotiations
Total expected time to hire is 3 to 4 weeks.
Please submit your CV in PDF format.
AgeMate is an Australian founded brand dedicated to enhancing longevity through innovative nutritional products. Since ****, we have supported customers across Australia, New Zealand, the United Kingdom, and the United States, helping over 150,000 people with thousands of positive reviews.
Join a passionate, down to earth team and play a key role in building scalable product quality, safety, and regulatory capability as the business grows.
#J-*****-Ljbffr

📌 Regulatory Affairs & Quality Manager (Melbourne)
🏢 AgeMate
📍 Melbourne

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