Job Summary

• Leads Regulatory Affairs function for regulatory compliance in healthcare business.
• Provides regulatory strategic directions and solutions for regulatory affairs.

General Responsibilities

• Develop, communicate and implement the strategic direction of the operation and also coordinates all presentations, inquiries and responses involving federal and state regulatory and legislative groups.
• Liaise with government to ensure business meet regulatory compliances.
• Give full accountability for the function and provide the highest level of advice and recommendations on company regulatory and quality compliance.
• Ensure the regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.
• Support subordinate to develop SOP/WI/SD for regulatory affairs, pharmacovigilance and other relevant functions.
• Establish and maintain positive relationships with government agencies and other regulatory authorities and network/associations ; represent the organization before in matters regulatory, legislative, or industry standards agencies so that the organization’s interests are advanced.
• Assure all audits meet organization and government standards on products/processes. Consults related ongoing issues with the executive leadership team and make decision from management team.
• Risk Management - Monitor and provide regulatory risk analysis or completion of regulatory requirement to meet TFDA regulation. - Manage risk management or required document of client product agreed with client requirement/ PV agreement.

Functional Skills and Knowledge

• Regulatory Expertise
• English Proficiency
• Problem solving
• Time managemen

Education

• Bachelor’s Degree in Pharmacy or Science or related health product field.
• Minimum 10 years of experience in regulatory affairs career.