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

 

Job Title: Regulatory Affairs Manager/Specialist 

Location: Riyadh, Saudi Arabia

Reports to: Country Manager

Industry: Pharmaceuticals

"Saudi Nationals Preferred"

 

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 SFD, 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 Review dossiers (incl. DMF), ensure compliance, finalize eCTD/SDR submissions 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

Regulatory Intelligence

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

SFDA Liaison & Stakeholder Management

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

MAH & Localization Support

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 People management experience preferred Fluent in English; Arabic proficiency strongly preferred

Key Skills

SFDA regulatory expertise Strategic regulatory planning Stakeholder & authority liaison Dossier review & compliance Strong communication and leadership skills