Responsibilities:

• Independently contribute to routine regulatory activities for product portfolio assigned.

• Responsible for registration of new products and line extensions as planned to ensure the launch plan for product portfolio will be as scheduled.

• Responsible for products license renewal, company's licenses, GMP clearance, and amendment.

• Maintain the registration licenses up to date throughout the lifecycle of products as required by local regulations and as data emerges, where applicable.

• Ensure all changes and quality issues relevant to regulatory activities are well-managed in accordance with internal procedures.

• Provide regulatory input / recommendation to ensure the compliance with current applicable regulatory affairs laws and regulations.

• Assist in reviewing labeling and promotional materials to ensure the compliance with regulatory requirements.

• Establish and maintain excellent working relationships with local health authority where applicable and other local regulatory agencies, as required.

• Where applicable, contribute in regulatory association's working groups and/or other regulatory projects from time to time with supervision from manager.

• Perform other duties required by superior from time to time.

Qualifications / Experiences:

• Bachelor's degree in Pharmaceutical Sciences

• At least 5 years' experience in area of Regulatory Affairs responsible for pharmaceutical products

• Good command in English particularly writing skill

• Computer literacy-skill to use business applications

• Actively responsible, well organized and able to work as a team with a positive attitude and open minded

• Good collaboration with and communication to all relevant stakeholders