With over 15 years of experience in regulatory affairs across the Middle East and Africa (MEA), I bring a strategic approach to regulatory compliance, product lifecycle management, and stakeholder engagement. My expertise spans managing regulatory submissions, leading cross-functional teams, and executing global strategies for complex portfolios, with a proven track record of ensuring timely approvals and market access for a wide range of products i.a. specialty, oncology, respiratory, and ophthalmology.Key Career Achievements:🟡 Led regulatory affairs across 30 MEA countries for a broad Rx portfolio, including Specialty, Respiratory, Oncology, and Ophthalmology, collaborating with global teams (Switzerland, UK, Australia) at Mundipharma. Successfully registered a full specialty portfolio in all 30 markets, navigating diverse regulatory landscapes to ensure timely approvals.🟡 Received the Above and Beyond Award at NewBridge Pharmaceuticals for achieving the highest number of product approvals across MEA ahead of schedule, exceeding expectations for market entry.🟡 Developed and implemented regulatory strategies for new product registrations, lifecycle management, and market entry for Juniper Biologics, ensuring ongoing compliance across the GCC, Levant, and North African markets.Areas of Expertise:Regulatory Strategy Development & Implementation, Regulatory Compliance, Change Control Management, Regulatory Submissions, Team Leadership, Stakeholder Engagement, Product Lifecycle Management, Global Regulatory Affairs, Risk Assessment & Gap Analysis, Labelling & Packaging Compliance, Cross-Functional Team Collaboration, Portfolio Management, Project Management, Good Manufacturing Practices, GCC Compliance, PSUR, RTQ, Veeva RIM, Saudi Drug Registration SystemThroughout my career, I've been instrumental in aligning regulatory strategies with business objectives, working closely with commercial, medical, and marketing teams to optimize market access and secure successful product approvals. I have also built and nurtured strong relationships with external stakeholders, including Ministries of Health (MOH), regulatory authorities, and regional distributors. By fostering these partnerships, I ensure streamlined communication, regulatory alignment, and smooth product introductions into new markets, driving business success.Regulatory Affairs Manager | RA Manager | Senior Regulatory Affairs Manager | Senior Manager