Update local regulations and health authority requirements.
Coordinate with foreign and domestic companies to obtain the necessary documents.
Provide SOPs and implement pharmacovigilance based on PV guidelines.
Review the contents of CTDs and prepare them for the review of the Ministry of Health.
Product registration, license renewal, and submission of changes.
Follow up on all assigned activities in the company and the Ministry of Health correctly and regularly.
Requirements
Bachelor's or Master's degree.
At least 3 years of experience in the same position.
Excellent communication and presentation skills.
Outgoing and persuasive manner and negotiation skills.
Confidence and perseverance.
Patience and spontaneity.
Analytical and planning skills.
Flexible approach to work in order to adapt to changes.
Strong teamwork and networking skills.
Good knowledge of English.
Proficient in preparing and presenting documents required by the Food and Drug Organization.
Familiar with the organization's regulatory affairs, including obtaining and renewing drug and supplement licenses, obtaining and renewing IRC, source registration.
Mastery of the TTAC system.
Experience in writing SOPs and guidelines.
Familiar with contract manufacturing.
Teamwork experience.
Appropriate public relations to refer to relevant organizations.
