Job Description
<Job Responsibilities> 1. Regulatory affairs activities: - Newly register products and manage registered products (*) including changes, supplements, renewal and withdrawal, prepare documents and submit dossiers and communicate with Vietnamese regulatory authorities throughout each product lifecycle. (*) Registered products: finished drug products, potential candidates: medical equipment, veterinary drugs, biological products, food supplements, in addition to finished drug products. - Assist Head office in data/information gathering and dossier compilation for product registration submission and other related licenses, including progress monitoring and follow-ups with authorities. - Provide regulatory support, update, advisory, and knowledge sharing for other departments and distributors to remain in compliance with the government regulatory requirements in Vietnam. - Support for all legal compliance matters. 2. Responsibility for Pharmacovigilance activities in accordance with company’s SOP and National guidelines. 3. Administration works appointed by Chief of Rep. office 4. Travel requirement flexible to respond to company request for company, regional training/ meeting.
Job Requirement
<Necessary Skill / Experience> ・Education: Bachelor's Degree in Pharma or equivalent. ・Language: English - Business Level (Reading, Translation, Listening and Speaking) ・Experience: Have at least 3 years of experience in Regulatory Affairs ・Other: - Good computer skills - Good communication, good at project management. - Hardworking and careful, positive mindset of customer satisfaction, teamwork and compliance.