Job Requirement
• Create and Establish a scientific approach to the company quality and regulatory system.
• Ensure all GMP, GLP, GCP operations are in compliance
, • Establish training and audit programs, as well as the review of SOPs, investigations, specifications, methods, validation reports, cleaning verification reports, analytical reports and manufacturing records.
• Develop strategies for regulatory approval and introduction of new products to market.
• Manage the process from development of regulatory strategies through to approval.
• Prepare and submit submissions and ensure compliance with all regulatory requirements pertaining to product approval.
• Ensure that all regulatory-related policies and procedures are current in accordance with applicable regulations and standards.
• Provide periodic update on regulatory requirement changes, which affect individual product specification or quality systems.
• Foster collaborative, efficient and effective working relations with regulatory authorities such as FDA.
• Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development.
• Be responsible for release or rejection of GMP materials and utilize QA staff to manage the timeline and assure on time delivery of approved materials.
• Act as company’s representative during regulatory agencies and customer inspections