وظيفة مشرف شؤون تنظيمية للأدوية لدى MRG بالرياض

Company Description MRG is a consultancy group founded in 2012 that provides regulatory and quality support to healthcare organizations across the pharmaceutical, medical device, and cosmetics sectors. The company delivers comprehensive solutions to help clients comply with regulatory requirements in KSA, Egypt, and the wider MENA region. With an experienced team and a focus on excellence, MRG offers regulatory consulting, submission management, and post-market compliance services to accelerate product approvals and market access. MRG also prioritizes training and development, providing tailored programs that keep professionals current with evolving industry standards and best practices.

Role Description The Regulatory Affairs Supervisor - Pharmaceutical is a full-time, on-site role based in Riyadh. This role oversees regulatory activities related to pharmaceutical products, including preparation, review, and submission of regulatory dossiers to local and regional authorities. The supervisor coordinates with cross-functional teams to ensure documentation accuracy, regulatory compliance, and timely approvals for new products, variations, and renewals. Day-to-day responsibilities include monitoring regulatory changes, maintaining product registration files, supporting audits and inspections, and advising internal stakeholders on regulatory strategies and requirements. The role may also involve contributing to training initiatives, guiding junior team members, and supporting clients in navigating complex regulatory frameworks within the MENA region.

You will supervise the pharmaceutical registration team and own the full SFDA drug registration lifecycle for our clients - from pre-submission strategy through approval and post-approval maintenance.

• Supervise and mentor the pharmaceutical registration team, assigning workloads, reviewing submissions, and ensuring quality and SLA compliance
• Lead new drug registration submissions to SFDA (SDR portal), including dossier preparation and review in eCTD/CTD format
• Manage product lifecycle activities: renewals, variations, and post-approval commitments
• Act as the primary point of contact with SFDA on pharmaceutical submissions, responding to queries and deficiency letters within deadlines
• Advise international clients on Saudi regulatory strategy, requirements, timelines, and pricing submissions
• Monitor SFDA regulations, guidelines, and circulars; communicate changes internally and to clients
• Oversee pharmacovigilance (PV) activities for client products in line with SFDA PV requirements: adverse event/ICSR reporting, PSUR/PBRER submissions, risk management plans, and safety variations
• Act as (or support) the local Qualified Person for Pharmacovigilance (QPPV/LQPPV) contact point with SFDA's National Pharmacovigilance Center
• Support GMP clearance, CPP/legalization requirements, and coordination with manufacturers' RA teams
• Maintain accurate registration trackers and report department KPIs to management

• Bachelor's degree in Pharmacy (B.Pharm or PharmD) - required
• Valid SCFHS (Saudi Commission for Health Specialties) professional classification and registration as a pharmacist (Mumaris Plus) - required
• Working knowledge of SFDA pharmacovigilance requirements (ICSR/adverse event reporting, PSURs, RMPs); QPPV/LQPPV experience is a strong plus
• 5-7 years of pharmaceutical regulatory affairs experience in Saudi Arabia, including at least 2 years in a supervisory or team-lead role
• Hands-on experience with SFDA drug submissions through the SDR portal, including eCTD dossier compilation, variations, and renewals
• Strong knowledge of SFDA regulations, GCC/ICH guidelines, and CTD structure
• Fluent Arabic and English (written and spoken) - required
• Excellent client communication, organization, and team-leadership skills
• Experience in a regulatory consultancy or agent/distributor environment is a plus

• A leadership role in one of Saudi Arabia's fastest-growing regulatory consultancies
• Direct exposure to international manufacturers and diverse product portfolios
• Competitive salary and benefits
• Professional development and growth within an expanding organization

To apply: Submit your CV via LinkedIn or email jobs@mrg.com.sa