Regulatory Affairs & Quality Manager (Melbourne)

Regulatory Affairs & Quality Manager (Melbourne)

02 Sep
|
AgeMate
|
Melbourne

02 Sep

AgeMate

Melbourne

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AgeMate is an Australian founded company in the longevity space, marketing a quick 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.

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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.

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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.

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- 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

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- 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

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- 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

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- 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

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- Support ongoing compliance of products listed on the Australian Register of Therapeutic Goods (ARTG)
- Support ARTG listings and regulatory requirements associated with recent 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

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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

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- 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 transparent 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

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Applicants must have full working rights in Australia.

Applicants must be based in Victoria.

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- Application Review
- 45 Minute Video Interview
- Case Study
- Personality Psychometric Assessment
- In Person Meeting at our Melbourne Office
- Formal Offer and Contract Negotiations
- Total expected time to hire is 3 to 4 weeks.

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?????? ???? ???????????: 3 days in the office, 2 days from home

????? ?????? ???????????: No suit required

?????????? ????????: 5 minute walk from Richmond Station

?????? ?????????: End of trip facilities including showers and towels, sauna, rooftop basketball court, and golf simulator

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Please submit your CV in PDF format.

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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.

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

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