Regulatory Pharmacist

Responsibilities:

• PRC license will be registered under the MOS LTOs.
• Maintain and oversee the Licenses to Operate (LTOs) of the Marketing Authorization Holder (MOS).
• Address and resolve formulation-related queries from internal teams and manufacturers.
• Ensure drug safety compliance through the review and monitoring of product information and documentation.
• Provide health science and technical information to support the sales and marketing teams.
• Review, check, and correct documents submitted by manufacturers to ensure regulatory accuracy and completeness.
• Conduct research and prepare technical and regulatory documentation required for submissions.
• Prepare and submit applications, particularly for medical devices and drug products that require technical evaluation.
• Assist in regulatory applications, especially those involving extensive documentation, such as LTO renewals and new registrations.