Regulatory Affairs Specialist

The successful candidate will be responsible for supporting regulatory, quality, and operational activities associated with the registration, maintenance, and compliance of products and processes.

Key responsibilities include:

• Prepare and maintain documentation required for the registration of new and existing products and processes.
• Prepare responses to regulatory queries and requests from relevant regulatory authorities.
• Define and maintain statutory requirements associated with the introduction of new products and changes to existing products.
• Retrieve and analyse data from Laboratory Information Management Systems (LIMS) to support the preparation of regulatory and customer stability reports.
• Review and approve Master Quality Control (QC) and Master Process documentation, including Certificates of Analysis (CoAs).
• Support relevant departments with queries relating to registered documentation and ensure that all documentation remains compliant with current regulatory requirements.
• Assess the impact of changes to registered documentation and ensure appropriate regulatory implications are identified and addressed.
• Work collaboratively with relevant departments to prepare and maintain the Site Master File.
• Prepare Product Quality Reviews (PQRs) in accordance with applicable legislation and regulatory requirements.
• Participate in internal and external audits as required, supporting the preparation, execution, and follow-up of audit activities.
• Participate in relevant Quality Management System (QMS) risk assessments.
• Review Annual Product Quality Complaints (APQCs) on a weekly basis, including maintenance of the Finished Product Registration Table and Packaging Subcontractor Table.
• Review Certificates of Analysis (CoAs) to ensure accuracy, completeness, and compliance with approved requirements.
• Participate in site performance meetings and provide relevant quality and regulatory input.
• Maintain a strong focus on compliance, documentation control, data integrity, and continuous improvement across all activities.

Key Competencies

• Strong understanding of GMP, Quality and Regulatory requirements .
• Excellent attention to detail and documentation skills.
• Ability to interpret technical and regulatory documentation.
• Strong organisational and time-management skills.
• Effective communication and cross-functional collaboration skills.
• Ability to manage multiple priorities and work to deadlines.
• Strong analytical and problem-solving capabilities.
• Proactive approach to identifying compliance risks and supporting continuous improvement.