QA Regulatory Affairs Specialist

QA Regulatory Affairs Specialist
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.