Regulatory Manager

Job title : Regulatory Manager Hiring Manager: Head of Site Quality Location: Jurong, Singapore About the Job The Head of Regulatory Site is responsible to assist the Head of Site Quality for ensuring compliance with relevant worldwide Pharmaceutical Regulation & API regulatory filing (e.g. CEP,CMC, Drug Master File (DMF), New Drug Application (NDA), JNDA, NDS & Marketing Authorisation Application (MAA) of the site. Main accountabilities: Defining the potential regulatory impacts of changes made to the site's processes and procedures; ensuring compliance with relevant worldwide Pharmaceutical Regulation & API regulatory filing; providing guidance on regulatory requirements and expectations; coordinating and facilitating internal audits and inspections; identifying and mitigating risks related to non-compliance; and maintaining accurate records of all regulatory activities. Key responsibilities: Developing and implementing a comprehensive regulatory strategy for the site; ensuring that all regulatory submissions are complete, accurate, and compliant with relevant regulations; providing training and guidance on regulatory requirements to site personnel; and collaborating with other departments to ensure compliance with company policies and procedures. Requirements: Bachelor's degree in Life Sciences or related field; at least 5 years of experience in a regulatory role; strong understanding of pharmaceutical regulations and guidelines; excellent communication, interpersonal, and problem-solving skills; ability to work independently and as part of a team; and proficiency in MS Office.