Regulatory Affairs Senior Manager
On-site · Riyadh, Riyadh Region, Saudi Arabia
Job Summary
Lead, manage, and execute regulatory strategies for the KSA, overseeing the country regulatory team and coordinating with regional and global stakeholders to develop and implement regulatory plans for new registrations and post-approval submissions. Ensure regulatory documentation meets requirements, align regulatory strategies with broader business objectives, and maintain timely submissions. Build and develop the in-country regulatory team, foster relationships with stakeholders, and oversee that submission plans are defined and executed, including liaison with Global Regulatory, Submissions Management, and Quality teams. Requires hands-on execution in-market and direct reports management. Requires a Bachelor’s degree in Chemistry, Pharmacy, or related life sciences, 10+ years of regulatory affairs experience, SCFHS licensure, and strong leadership/communication skills.
Required Qualifications
- Bachelor’s degree in Chemistry, Pharmacy, or a related life sciences
- Licensed from SCFHS (Saudi Commission for Health Specialties)
- Minimum 10 years of experience in regulatory affairs
- Experience with NDA, sNDA, ANDA, MAA submission processes
- Experience in regulatory affairs for human medicines
- Strong leadership and management capabilities
- Ability to influence at all levels and manage complex regulatory issues
- Regulatory environment knowledge (regional and global)
- Knowledge of CMC submissions and regulatory requirements
Additional Requirements
- Saudi national
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