Job description

The Manager - Regulatory Affairs at Julphar is responsible for the operational implementation and execution of submission and approval plans across markets. The role involves managing and leading the life cycle management team and overseeing drug product renewals and variations. The manager provides technical and scientific guidance to navigate dynamic regulatory challenges worldwide, establishes proactive dialogue with regulatory authorities, evaluates timely submissions for license renewal and variations, safeguards corporate regulatory databases, and provides regulatory strategy and innovative business solutions. The role monitors monthly Regulatory Affairs performance, liaises with specialized RA personnel to meet submission requirements, collaborates with PDL, QA, QC, Tender, Marketing, and Accounts Departments, manages all aspects of regulatory projects including strategy, resources, costs, time, and clients, and assumes responsibility for functional areas within the department while selecting methods and processes to achieve objectives. Key expertise includes understanding regulatory disciplines, principles, concepts, and theories governing Regulatory Affairs, successful submission, approval, and post-approval management in health agencies, and full knowledge of regulatory requirements across multiple regions and industry best practices for drug development.