Regulatory Affairs Manager
Current• Provides regulatory support to cross-functional project teams. • Prepares core dossiers and provides support for major market regulatory approvals.• Compilation of submission dossiers through the eCTD software.• Manages product submissions concurrently in several countries with significantly differing regulatory schemes.• Ensure regulatory compliance of market-released products.• Support the RA director in regional product registration strategy and planning.• Provides regulatory support, and leadership to project teams for regulatory issues and questions and ensures that regulatory requirements are addressed before submission for market clearance.• Works closely with Marketing, Manufacturing, Quality Assurance, R&D, and BD teams to provide regulatory guidance and review.• Manage with distributors and agents to prepare and maintain product submissions and licenses.• Understands global regulatory requirements and establish and maintains good working relationships with regulatory agency personnel.• Evaluate proposed product changes for regulatory impact and prepare necessary documentation.• Regulatory intelligence database update with close follow-up of the latest circulars and guidelines issued from the MOH, and immediate implementation within the company.• Overview on pricing methodologies across MENA region and ensure they are in line with followed regulations to avoid any negative price impact on company's products.• Regulatory support for the tender business.• Prepare, review, and release the artwork in coordination with the countries and the manufacturing site.• Ensure that all regulatory documents and correspondences with HA are archived properly.• Stay aware of up-to-date regulations and requirements in the designated region.
