Regulatory Affairs Specialist

About This Role

This Regulatory Affairs Specialist role involves coordinating the preparation and submission of regulatory documents for the company's products, ensuring compliance with relevant standards. The specialist will also maintain regulatory documentation databases and track pipeline status with governmental agencies. The position suits a professional with experience in the pharmaceutical industry.

Responsibilities

• Coordinate the preparation and submission of regulatory documents for Parkville’s products, ensuring compliance with relevant standards
• Stay updated on changes to economic, registration, and submission guidelines, maintaining regulatory documentation databases accordingly
• Conduct weekly visits to the Ministry of Health to track pipeline status and address any required modifications during the registration and variation phases
• Review product specifications, labeling, and batch records for compliance with applicable regulations and prepare necessary importation approvals for active pharmaceutical ingredients (APIs)
• Respond to governmental agencies' requests for product data and regulatory affairs statements, ensuring timely communication
• Compile and organize re-registration files in accordance with ministerial decrees, ensuring all documentation is complete and accessible
• Develop and review product leaflets (SPC & PIL) and submit them to the appropriate regulatory authorities for approval
• Prepare and maintain required stability files, bioequivalence files, and analytical dossiers for submission to regulatory bodies of Health / CAPA

Requirements

• Bachelor’s degree from a reputable university
• Degree in Pharmacy, Veterinary Medicine, or Science is an advantage
• 3-4 years of previous experience in the pharmaceuticals industry in the same position and responsibilities

About the Company

Parkville is committed to diversity, equity, and inclusion.