REGULATORY AFFAIRS ASSISTANT PHARMACEUTICALS

The Regulatory Affairs Assistant supports the RA team in preparing, reviewing, tracking and maintaining regulatory dossiers and product documents for the Vietnam market and Indochina.
Working under the guidance of senior RA personnel, the successful candidate will coordinate with manufacturers, consultants and internal teams to support product registration, post-registration activities and regulatory compliance throughout the product lifecycle.
KEY RESPONSIBILITIES
1. Regulatory Document Review and Compliance Support
· Assist in checking artwork (AW), package inserts (PI), certificates of analysis (COA), specifications and other product documents against the latest versions approved by the Drug Administration of Vietnam (DAV).
· Identify discrepancies and report them to the responsible RA personnel for review and guidance before production and shipment.
· Follow up with manufacturers on document corrections and updates as instructed by the RA team.
· Maintain approved documents, registration records and regulatory trackers, ensuring accurate filing and version control.
2. Registration and Post-Registration Support
· Assist in compiling and preparing dossiers for product registration, renewal, variation and responses to requests for additional information.
· Collect and check supporting documents for completeness, consistency and format under the guidance of senior RA personnel.
· Track DAV correspondence, deficiency comments, submission progress and registration status.
· Monitor registration expiry dates and relevant deadlines, and promptly notify the responsible RA personnel of required follow-up actions.
3. Regulatory Updates and Other Documentation Support
· Monitor relevant regulatory updates and prepare summaries for review by the RA team.
· Support regulatory documentation for other product categories, including supplements, cosmetics and medical devices, as assigned.
· Assist with trademark registration, renewal and related document follow-up.
· Compile approved regulatory and product documents for customers, distributors and business partners as instructed.
4. Coordination and Administrative Support
· Coordinate with manufacturers, consultants and internal departments to collect documents and follow up on pending regulatory matters.
· Prepare progress updates and maintain records of outstanding tasks and deadlines.
· Escalate missing documents, inconsistencies and potential delays to the responsible RA personnel in a timely manner.
· Perform other duties related to the role as assigned.
QUALIFICATIONS
· Bachelor's degree in Pharmacy or a relevant scientific discipline.
· Fresh graduates are welcome to apply. Up to one year of experience in Regulatory Affairs, QA, QC, pharmaceutical manufacturing or a related field is an advantage.
· Basic understanding of pharmaceutical products and regulatory documentation.
· Good English reading and writing skills, with the ability to communicate by email and work with technical documents.
· Proficiency in Microsoft Word, Excel and other standard office applications.
· Careful, organized and responsible, with strong attention to detail.
· Ability to manage assigned tasks, meet deadlines and seek guidance when necessary.
· Willingness to learn and develop a career in pharmaceutical Regulatory Affairs.
ADDITIONAL ADVANTAGES
· Familiarity with pharmaceutical dossier preparation, document review or regulatory submissions in Vietnam or other markets.
· Basic knowledge of pharmacovigilance.
· Familiarity with CorelDRAW or Adobe Illustrator for checking artwork or assisting with basic updates under supervision.
KEY SKILLS
· Document checking and attention to detail.
· Document management, filing and version control.
· Task tracking, time management and prioritization.
· Communication, teamwork and coordination.
· Confidential handling of company and product information.
BENEFITS
· Five-day working week, Monday to Friday.
· Opportunity to gain practical experience in pharmaceutical Regulatory Affairs through coordination with international manufacturers.
· Training and guidance from experienced RA colleagues.
· Company-provided working equipment.
· Social, health and unemployment insurance in accordance with applicable regulations.
· Other benefits in accordance with Vietnamese labor law and company policy.