Regulatory Affairs Supervisor — Pharmaceutical

About MRG

MRG is a leading consultancy group established in 2012, specializing in regulatory and quality support for healthcare organizations across the pharmaceutical, medical device, and cosmetics industries. With a robust presence in the Kingdom of Saudi Arabia, Egypt, and the broader MENA region, MRG delivers end-to-end solutions designed to ensure seamless compliance with evolving regulatory frameworks. Our services encompass regulatory consulting, dossier submission management, and post-market compliance, all aimed at accelerating product approvals and enhancing market access for our clients. Committed to professional growth, MRG invests in training and development initiatives that empower teams to stay ahead of industry trends and regulatory best practices.

Position Overview

The Regulatory Affairs Supervisor — Pharmaceutical is a full-time, on-site role based in Riyadh, Saudi Arabia. This pivotal position is responsible for overseeing all regulatory activities pertaining to pharmaceutical products, including the preparation, review, and submission of comprehensive regulatory dossiers to local and regional authorities. The supervisor will collaborate closely with cross-functional teams to ensure meticulous documentation, unwavering regulatory compliance, and timely approvals for new product registrations, variations, and renewals. Core responsibilities include monitoring regulatory updates, maintaining up-to-date product registration files, supporting audits and inspections, and providing strategic regulatory guidance to internal stakeholders. Additionally, the role may involve contributing to training programs and mentoring junior team members to foster a culture of excellence and continuous improvement.

Key Responsibilities

• Team Leadership and Management: Supervise and mentor the pharmaceutical registration team, delegating tasks, reviewing submissions, and ensuring adherence to quality standards and service level agreements (SLAs).
• Regulatory Submission Oversight: Lead the preparation and submission of new drug registrations to the Saudi Food and Drug Authority (SFDA) via the SDR portal, including dossier compilation and review in eCTD/CTD format.
• Product Lifecycle Management: Oversee product lifecycle activities, including renewals, variations, and post-approval commitments, ensuring ongoing compliance with regulatory requirements.
• Regulatory Authority Liaison: Serve as the primary point of contact with the SFDA for pharmaceutical submissions, addressing queries and deficiency letters within stipulated deadlines.
• Client Advisory: Provide strategic regulatory guidance to international clients regarding Saudi-specific requirements, timelines, and pricing submissions, ensuring alignment with local regulations.
• Regulatory Intelligence: Monitor SFDA regulations, guidelines, and circulars, communicating critical updates to internal teams and clients to facilitate proactive compliance.
• Pharmacovigilance Oversight: Lead pharmacovigilance (PV) activities for client products in accordance with SFDA PV requirements, including adverse event/ICSR reporting, PSUR/PBRER submissions, risk management plans, and safety variations.
• Qualified Person for Pharmacovigilance (QPPV/LQPPV): Act as the local QPPV or support the designated contact point with the SFDA’s National Pharmacovigilance Center.
• GMP and Compliance Support: Facilitate GMP clearance processes, coordinate Certificate of Pharmaceutical Product (CPP) legalization, and collaborate with manufacturers’ regulatory affairs teams.
• Reporting and Documentation: Maintain accurate registration trackers and compile departmental KPI reports for management review.

Qualifications and Experience

• Education: Bachelor’s degree in Pharmacy (B.Pharm or PharmD) is required.
• Professional Registration: Valid SCFHS (Saudi Commission for Health Specialties) professional classification and registration as a pharmacist (Mumaris Plus) is mandatory.
• Pharmacovigilance Knowledge: Working knowledge of SFDA pharmacovigilance requirements, including ICSR/adverse event reporting, PSURs, and RMPs; prior experience as a QPPV/LQPPV is highly advantageous.
• Regulatory Experience: Minimum 5–7 years of pharmaceutical regulatory affairs experience in Saudi Arabia, with at least 2 years in a supervisory or team-lead capacity.
• Technical Proficiency: Hands-on experience with SFDA drug submissions via the SDR portal, including eCTD dossier compilation, variations, and renewals.
• Regulatory Knowledge: In-depth understanding of SFDA regulations, GCC/ICH guidelines, and CTD structure.
• Language Skills: Fluency in both Arabic and English (written and spoken) is required.
• Soft Skills: Exceptional client communication, organizational abilities, and team leadership skills are essential.
• Industry Experience: Prior experience in a regulatory consultancy or agent/distributor environment is considered a valuable asset.

What We Offer

This leadership role presents a unique opportunity to shape the regulatory strategies of leading healthcare organizations in one of the fastest-growing markets in the MENA region. Successful candidates will benefit from a dynamic work environment, professional development opportunities, and the chance to contribute to high-impact projects that drive regulatory excellence. MRG is committed to fostering a culture of innovation, collaboration, and continuous learning, ensuring that our team members are equipped to meet the evolving demands of the pharmaceutical industry.