Regulatory Affairs Manager/ Senior Regulatory Affairs Executive

- Planning and managing registration of assigned products • To ensure that all new products are registered within the time-frame upon the launching schedule of commercial • To ensure that renewals of the existing products are obtained timely for the supply continuity. • To ensure that all technical changes are submitted and approved within in the time-frame upon the implementation. • To ensure that all labelling updates are submitted and approved within the Target Submission Category (TSC) and aligned with the global prescription information. - Regulatory consultation: • To provide regulatory consultation and analysis based on experience, expertise, knowledge of local regulation and regulatory environment to line manager, other functional departments, above country. - Risk management: • Periodically to identify and evaluate risks in the activities and operation of the departments and accordingly propose and take actions to mitigate impacts to the business operation and objectives. - Process improvements: • Continuously review and make the appropriate changes in order to improve the internal and cross-functional process. - QMS compliance and GSK policies. - Others: Perform of CMC variation (Vx), Vx Advocacy

Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: • Bachelor • Describe what experience this position will require the job holder to have obtained in past roles within or outside of GSK that would demonstrate a level of proficiency in the stated role. • Taking charge of registration of vaccines, pharma products: building plan for registration, communicating with liaison and CMC team to get appropriate documents as well as finding the best solution, following up progress of dossier assessment, developing artwork and keeping regulatory system updated. • Collaborating with Marketing to build strategy for vaccine and new products (NCEs) • Supporting local vaccine release (providing documents, cold chain system, solving issues related to vaccine release in Vietnam) and supply activities • Updating drug legislation • In-depth knowledge of vaccines and pharmaceutical products and regulation. • Experience at least 05 years in regulatory work and environment. • Regulatory Technical Skills Preferred Qualifications: If you have the following characteristics, it would be a plus: • List any licenses, certificates, registrations, or any relevant job skill or abilities not covered in Educational Background or Job-Related Experience sections above that are required for the job.