Coordinate with relevant stakeholders including importers, warehouse, distributors, and support for any regulatory matters/ requirements.
Planning, organizing, and submitting various regulatory data packages and completing these registration processes in timely manner to support business growth in Vitenam.
Develop regulatory plans with the commercial department and execute these plans according to the priority list and timeline agreed.
Analyze the product registration requirements/options in Vietnam and propose action plan for the speedy registration.
Prepare/request product registration dossiers based on local registration requirements.
Visit the local regulatory agencies responsible for the registration of the product concerned to find the most practical way to get a product registered.
Maintain existing registrations (e.g., renewal, variations) and ensure regulatory compliance between the recent updated information and the registered information of the product at relevant authority/authorities.
Identify and interpret relevant regulatory guidelines and advise others on regulatory and compliance matters.
Closely monitor new regulations/requirements and ensure compliance with regulations.
Qualifications:
Bachelor's degree in life sciences or related field (preferred)
Minimum of 5 years hands-on registration experience, highly desirable to have at least 3-5 years in Animal Health Industry
Direct experience with various regulatory bodies in Vietnam is highly desirable
Experience with veterinary drugs is desirable (Vaccine registration experience is a plus)
Able to work independently, have excellent planning and organizing skills and effective verbal and written communication skills both vietnamese and english
Ability to multi-task and prioritize multiple projects
Be resourceful and be willing to take up new tasks and responsibilities
Proficient in Microsoft Office products (Excel, Word, Access, PowerPoint and Outlook)
