Regulatory Affairs Supervisor

Role Overview

The Regulatory Affairs Supervisor is tasked with overseeing the preparation, submission, and comprehensive management of pharmaceutical registration dossiers in alignment with SFDA and international regulatory standards within the ARAC region. The position ensures the efficient registration process including variations, renewals, maintenance, and compliance with marketing authorizations via effective dossier administration and eCTD publishing.

Key Responsibilities

• Draft and submit pharmaceutical registration dossiers to the Saudi Food and Drug Authority (SFDA) and other relevant regulatory bodies.
• Handle registration processes, amendments, renewals, responding to deficiencies, and managing post-approval modifications.
• Ensure adherence to CTD/eCTD guidelines alongside SFDA regulations and ICH protocols.
• Track submission deadlines and maintain comprehensive regulatory schedules.
• Compile, publish, validate, and manage electronic Common Technical Document (eCTD) submissions and their lifecycle sequences.
• Ensure correct organization of documentation within Modules 1 through 5.
• Conduct technical validation and resolve any issues related to eCTD publishing.
• Maintain electronic archives and all related regulatory documentation.
• Review and systematically organize regulatory documents sourced from manufacturers and partners.
• Prepare relevant application forms, labeling materials, product information declarations, and other regulatory paperwork.
• Stay updated on regulatory changes and evaluate their potential impact on existing product registrations.
• Assist in regulatory audits, inspections, and ongoing compliance activities.

Qualifications and Experience

• Bachelor's degree in Pharmacy is essential.
• A Master's degree specializing in Regulatory Affairs or a related field is considered a plus.
• At least six years of experience in a comparable regulatory role within the pharmaceutical sector.

Language Skills

• Fluency in English is mandatory.
• Proficiency in Arabic is preferred.