Tuyển dụng Regulatory Affairs Assistant – Pharmaceuticals tại Hồ Chí Minh

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.

Yêu cầu ứng viên

QUALIFICATIONS

·         Bachelor’s degree in Pharmacy or a relevant scientific discipline.

• 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.

Quyền lợi được hưởng

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.