Regulatory Affairs Manager

Overview

Our client, a leading Indian multinational pharmaceutical company, is seeking a Regulatory Affairs Manager/Specialist for their newly established facility in Riyadh, Saudi Arabia. This role supports Saudization initiatives and will focus on ensuring compliance with Saudi regulatory requirements.

Job Title

Job Title: Regulatory Affairs Manager SFDA - Experienced

Reports to

Reports to: Country Manager

Note: Candidate must have experience working with SFDA (Saudi Food & Drug Authority)

Job Summary

The Senior Manager - Regulatory Affairs will lead SFDA regulatory activities for Saudi Arabia, ensuring timely product registrations, lifecycle management, and ongoing compliance. The role acts as the primary liaison with SFDA, PV, and Quality teams across product development, registration, and commercialization.

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 single 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
• 10 +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

Key Skills

• SFDA regulatory expertise
• Strategic regulatory planning
• Stakeholder & authority liaison
• Strong communication and leadership skills