QA Regulatory Affairs Specialist

DPS Group Global; Leinster; On-site; AUD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive compensation & benefits

Regulated manufacturing environment

Exposure to regulatory/quality/comli

Job summary

DPS Group Global in Australia is seeking a Regulatory & Quality Operations professional to prepare and maintain regulatory documentation, support product registrations, and manage stability data and reports across the product lifecycle.

You will review quality documentation, provide compliance guidance, support audits, CAPAs, and contribute to continuous improvement with cross-functional teams in Quality, Manufacturing, Technical Operations, and Supply Chain.

Responsibilities

• Prepare and maintain regulatory documentation to support product registrations, variations, renewals, and responses to regulatory authority requests.
• Coordinate and review stability data and associated reports to support product lifecycle activities and regulatory submissions.
• Generate and maintain stability documentation and related reports using internal quality systems.
• Review and approve quality documentation, including product specifications, quality control documentation, certificates, and manufacturing records.
• Provide regulatory and compliance guidance to internal stakeholders regarding approved product documentation and quality requirements.
• Manage change control activities and assess the potential regulatory impact of proposed changes.
• Support the preparation and maintenance of site and product regulatory documentation.
• Assist with internal audits, quality system reviews, and continuous improvement initiatives.
• Participate in quality risk management activities and support regulatory compliance assessments.
• Review product documentation associated with manufacturing, packaging, and supply chain partners to ensure ongoing compliance.
• Support product quality review activities and contribute to periodic quality reporting requirements.
• Assist in the review and management of corrective and preventive actions (CAPAs) and related quality records.
• Participate in cross-functional meetings and provide regulatory and quality input to support business objectives.
• Support compliance with applicable regulatory requirements, industry standards, and company quality procedures.

Job description

• Competitive salary and comprehensive benefits package.
• Opportunity to work within a well-established, highly regulated manufacturing environment.
• Exposure to a broad range of regulatory, quality, and compliance activities across the product lifecycle.
• Collaborative culture with strong cross-functional engagement across Quality, Manufacturing, Technical Operations, and Supply Chain.
• Ongoing professional development and career progression opportunities.
• The chance to make a meaningful impact on product quality, regulatory compliance, and continuous improvement initiatives.

Why Join?

• Competitive salary and comprehensive benefits package.
• Opportunity to work within a well-established, highly regulated manufacturing environment.
• Exposure to a broad range of regulatory, quality, and compliance activities across the product lifecycle.
• Collaborative culture with strong cross-functional engagement across Quality, Manufacturing, Technical Operations, and Supply Chain.
• Ongoing professional development and career progression opportunities.
• The chance to make a meaningful impact on product quality, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

Regulatory & Quality Operations

• Prepare and maintain regulatory documentation to support product registrations, variations, renewals, and responses to regulatory authority requests.
• Coordinate and review stability data and associated reports to support product lifecycle activities and regulatory submissions.
• Generate and maintain stability documentation and related reports using internal quality systems.
• Review and approve quality documentation, including product specifications, quality control documentation, certificates, and manufacturing records.
• Provide regulatory and compliance guidance to internal stakeholders regarding approved product documentation and quality requirements.
• Manage change control activities and assess the potential regulatory impact of proposed changes.
• Support the preparation and maintenance of site and product regulatory documentation.
• Assist with internal audits, quality system reviews, and continuous improvement initiatives.
• Participate in quality risk management activities and support regulatory compliance assessments.
• Review product documentation associated with manufacturing, packaging, and supply chain partners to ensure ongoing compliance.
• Support product quality review activities and contribute to periodic quality reporting requirements.
• Assist in the review and management of corrective and preventive actions (CAPAs) and related quality records.
• Participate in cross-functional meetings and provide regulatory and quality input to support business objectives.
• Support compliance with applicable regulatory requirements, industry standards, and company quality procedures.