Associate Director, Regulatory Affairs

Job Description Key Responsibilities Lead and develop the Regulatory Affairs team, providing clear direction and people management. Develop and execute regulatory strategies to secure timely approvals and maintain optimal product positioning. Ensure timely submission, approval, and lifecycle management of marketing authorisations, including new applications, variations, renewals, and major indications. Provide strategic regulatory guidance to support product development, launches, business development, and market access initiatives. Maintain compliance with local regulatory requirements, company policies, and quality standards. Monitor and communicate regulatory intelligence, legislative changes, and emerging regulatory trends.…