Assistant General Manager Regulatory Affairs

Bangkok - Thailand

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

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 organizations 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

Bachelors Degree in Pharmacy or Science or related health product field.
Minimum 10 years of experience in regulatory affairs career.

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Required Experience:

Director

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 pr...