Regulatory Affairs & Quality Manager (Melbourne)

Regulatory Affairs & Quality Manager (Melbourne)

18 Sep
|
AgeMate
|
Melbourne

18 Sep

AgeMate

Melbourne

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.

As a Regulatory Affairs & Quality Manager at AgeMate, you will play a critical role in ensuring the safety, quality, and regulatory AUSTL sponsor side 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 escalate 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 setting.

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.

AgeMate is an Australian founded brand dedicated to enhancing longevity through innovative nutritional products. Since 2022, 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.

Your application will include the following questions:

- Which of the following statements best describes your right to work in Australia?
- Have you worked in a role which requires a sound understanding of TGA Regulations?

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

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