Regulatory Affairs Manager SFDA Experienced

Our client, a leading multinational pharmaceutical company, is looking to hire a Regulatory Affairs Manager for their operations in Riyadh, Saudi Arabia. (Saudization)

Job Title: Regulatory Affairs Manager SFDA Experienced

Reports to: Country Manager

Budget: SAR 32,000 - 35,000 + Benefits

Job Summary

The Regulatory Affairs Specialist will manage SFDA regulatory activities in Saudi Arabia, supporting product registrations, lifecycle management, and compliance, while coordinating with PV and Quality teams.

Key Responsibilities Regulatory Submissions & Lifecycle Management

• Manage new registrations, renewals, variations, and deficiency responses with SFDA
• Track approvals, handle appeals, and maintain product licenses across lifecycle
• Review and approve labelling, SPC, PIL, and bilingual artworks

Regulatory Strategy & Portfolio Support

• Provide regulatory input on portfolio selection, RLD availability, and filing routes
• Support product development with early regulatory guidance
• Conduct regulatory due diligence for in-licensing and localization projects
• Monitor and communicate SFDA guidelines, circulars, and regulatory updates
• Advise on bioequivalence, biowaivers, exemptions, and complex filings
• Benchmark industry practices and support strategy for complex products
• Act as point of contact with SFDA for submissions, meetings, inspections
• Arrange and participate in pre-submission meetings and inspections
• Provide regular status updates to internal stakeholders
• Support MAH responsibilities, PV coordination, brand name approvals
• Provide input on patents, data exclusivity, tech transfer, and local manufacturing
• Identify SFDA-approved packaging/manufacturing sites

Documentation & Translation

• Oversee Arabic-English translations of dossiers, artworks, and PILs
• Support COPP applications for registrations in other markets

Qualifications & Experience

• Bachelor's or Master's degree in Pharmacy
• Prior experience working with the Saudi Food & Drug Authority (SFDA)
• 7 +years of Regulatory Affairs experience in Saudi Arabia pharma industry
• Strong hands on experience with SFDA regulations and submissions
• Fluent in English; Arabic proficiency strongly preferred