Regulatory Affairs Spv

Responsibilities Execute & monitoring product registration process Coordination with related department and Principal, review docs & prepare good registration dossier. Ensure all regulatory activities (new product, variation & renewal submission) are compliant with regulations, requirements and practices. Ensure to get approval as committed timeline Liaise with Manager & Dept. Head to get advises on regulatory strategy and approach. Develop good relations with internal & external stake holders

Requirements Has experience in regulatory affairs min 2 years for drug product registration Knowledge of the local regulatory affairs environment and how this impacts regulatory strategy and implementation, especially related to product registration requirement, regulation & quidelines. Strong communication and interpersonal skills. Detail-oriented with the ability to manage projects from inception through execution and tracking progress of projects to completion Proficiency in English both, written and spoken Good communication & negotiation skill Loyal & has a good responsibility, good teamwork Positive attitude Fast learning Proficiency in English both, written and spoken