Our client is a leading global pharmaceutical company.

Responsibilities

• Independently contributing to routine regulatory activities for the product portfolio assigned.
• Being responsible for the registration of new products and line extensions as planned to ensure the launch plan for the product portfolio will be as scheduled.
• Being responsible for product license renewal, company licenses, GMP clearance, and amendment.
• Maintaining the registration licenses up to date throughout the lifecycle of products as required by local regulations and as data emerges, where applicable.
• Ensuring all changes and quality issues relevant to regulatory activities are well-managed following internal procedures.
• Providing regulatory input/recommendation to ensure compliance with current applicable regulatory affairs laws and regulations.
• Assisting in reviewing labelling and promotional materials to ensure compliance with regulatory requirements.
• Establishing and maintaining excellent working relationships with local health authorities where applicable and other local regulatory agencies, as required.
• Where applicable, contributing to regulatory association’s working groups and/or other regulatory projects from time to time with supervision from the manager.
• Performing other duties required by superior from time to time.

Qualifications/Experiences

• Bachelor’s degree in Pharmaceutical Sciences.
• At least 5 years experience in the area of Regulatory Affairs responsible for pharmaceutical products.
• Good command of English particularly writing skills.
• Computer literacy-skill to use business applications.
• Actively responsible, well organized and able to work as a team with a positive attitude and open mind.
• Good collaboration with and communication with all relevant stakeholders.