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.