Regulatory Affairs Manager GCC and Saudi Arabia

Regulatory Affairs Manager GCC and Saudi Arabia Location: Dubai Science Park Department: Regulatory Affairs Job type: Full Time Reports To: Senior Director Regional Regulatory APAC and MEA Join us and make a difference when it matters most! At Mundipharma, we are proud of the work we do to bring innovative treatments to patients. We challenge ourselves constantly to deliver more for patients, healthcare professionals, our partners, and our employees. The Team Joining the Regulatory Affairs team at Mundipharma, the Regulatory Affairs Manager GCC and Saudi Arabia is responsible for leading and overseeing Regulatory Affairs activities across GCC and Saudi Arabia markets, ensuring effective execution, compliance, and alignment with global regulatory strategies. The role provides management oversight of regional Regulatory Affairs resources, delivering regulatory outcomes that support business priorities while operating within defined policies, procedures, and governance frameworks. The role holds accountability for team performance and regulatory delivery within the assigned markets, while receiving strategic direction from senior Regulatory Affairs leadership. Role and Responsibilities Regional Team Leadership: Lead, coach, and develop a team of internal and outsourced Regulatory Affairs professionals and analysts across the GCC and Saudi Arabia. End-to-End Regulatory Execution, overseeing all regional regulatory activities, including new marketing authorization applications, lifecycle maintenance, compliance obligations, and artwork/labeling content. Ensure regional regulatory activities are executed consistently in full alignment with global/regional strategies, local laws, and internal governance processes. Serve as the primary Regulatory Affairs liaison for Health Authorities and internal cross-functional partners (Commercial, Medical, Quality, PV, and Market Access). Provide technical regulatory insights and practical guidance to inform forecasting, operational planning, and market execution strategies. Risk Management & Compliance: Proactively identify, mitigate, and resolve regulatory risks within functional scope, escalating material issues to senior leadership as needed. Drive resource planning, workload prioritization, and capacity allocation across internal and external teams to meet operational demands. Exercise full people management accountability, including recruitment, performance evaluations, compensation decisions, and talent development. Process Optimization & Continuous Improvement: Identify and implement workflow improvements that align with global standards to enhance operational efficiency. Lead functional change initiatives while maintaining operational continuity and ensuring regulatory processes scale with market complexity. What you’ll bring Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related scientific discipline. A minimum of 5 years of total professional experience within Pharmaceutical or Healthcare Regulatory Affairs is required. Up to 2 years of experience in a similar managerial regulatory role managing teams or supervising regulatory professionals is required. Experience working within matrix organisations and collaborating with global and regional stakeholders is required. Proven experience managing resources, priorities, and regulatory delivery within defined functional boundaries is expected. Strong working knowledge of pharmaceutical regulatory frameworks across GCC and Saudi Arabia Demonstrated ability to manage professional teams and deliver regulatory outcomes within established governance frameworks. Solid understanding of regulatory lifecycle management submissions, new marketing applications and compliance requirements. Ability to make sound operational decisions guided by policies, procedures, and business plans. Experience addressing complex regulatory issues with impact beyond the immediate team. Strong planning, prioritisation, and problem-solving skills. Ability to provide practical regulatory guidance to internal stakeholders and customers. What we offer in return Benefits package Opportunities for learning & development through our varied programme Collaborative, inclusive work environment Diversity and inclusion Building an inclusive environment where people can thrive, grow and achieve their full potential is a priority. We believe this isn’t just the right thing, but also the smart thing to do. We are on a journey and will seek to move forward together through education and awareness to build a culture that welcomes and celebrates diversity and uniqueness. We will create a workplace environment where everyone can, every day, bring their authentic selves and is treated with dignity and respect. About Mundipharma Mundipharma is a global healthcare company focussing on customers across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of pain management, infectious disease as well as other severe and debilitating disease areas. Their guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything they do. For more information visit . Join our talent pool If you’re not sure this role is right for you but you’re keen to hear about future opportunities at Mundipharma, join our talent community and be the first to hear about new roles. Additional Job Description: Primary Location: AE Dubai Job Posting Date: 2026-08-07 Job Type: Permanent