Regulatory Affairs Consultant

Role Overview

This position involves managing regulatory affairs for pharmaceutical products with a focus on coordinating submissions, maintaining compliance, liaising with the Saudi Food and Drug Authority (SFDA), and supporting portfolio development and regulatory strategy implementation in Saudi Arabia.

Main Accountabilities

• Review and submit registration dossiers and variations, ensuring completeness and consistency with SFDA requirements; manage upload and tracking on relevant portals.
• Coordinate project activities, participate in teleconferences, and provide regulatory inputs on next steps.
• Facilitate product classification, pharmacological evaluations, and approval notifications while maintaining documentation and supporting compliance and labeling processes according to local guidelines.
• Prepare administrative documents (Module 1), perform thorough compliance checks, manage deficiency responses, and maintain product life-cycle authorizations including renewals and reports.
• Support due diligence for in-licensing, providing regulatory insight and dossier suitability evaluations.
• Contribute regulatory intelligence by monitoring SFDA updates, circulars, and guidelines; support clinical and bioequivalence queries; engage SFDA for clarifications and meetings as needed.
• Serve as the main liaison with SFDA and other key stakeholders including consultants and subject-matter experts; manage official communications, inspections, dossier submissions, and meeting coordination.
• Assist with MAH responsibilities including brand name support, patent/data exclusivity advice, and compliance coordination; aid business expansion through regulatory support for tech transfers and local manufacturing initiatives.
• Coordinate translation activities between Arabic and English for regulatory documents, artwork, and labeling materials.
• Manage Certificate of Pharmaceutical Product (COPP) applications for other countries and associated legalization processes.

Educational and Experience Requirements

• Bachelor's or Master’s degree in Pharmacy.
• Proficient in English (spoken and written) with knowledge of the local language.
• Minimum 9-10 years of regulatory affairs experience within a reputed pharmaceutical company in Saudi Arabia, including management of teams.