Drug Regulatory Affair Specialist

Responsibilities

1) Drug registration: Take fully ownership of all registration types and Marketing Authorization maintenance under assignments (New, renew and variation registration)

• Work with Global (RIR, RGLI, and relevant functions) and Portfolio Function (if applicable) to get sufficient document, dossiers, materials as applicable requirements for timely submission (new registration, renewal registration, variation registration, etc.) in compliance with relevant SOPs and regulations
• Follow up and work with relevant Authorities to handle question if any to get timely approvals
• Timely complete and submit all reports, tracking, archiving as per SOPs and regulations

2) GMP assessment and tender document support (for distributor):

• Ordering new GMPs, preparing application for submission, following up to get timely approval (posted in DAV website) for all SKUs under responsibilities.
• Manage all GMP registration matters.

3) Regulatory environment monitoring and influencing:

• Involve in monitoring the regulatory environment including competitor regulatory activities.
• Assess the regulation changes and impacts and propose the solutions

4) Projects/others:

• Supply document for SC, QA, tender (distributors) when required
• Support to follow up with HA to get approval for import licenses of toxicity and/or special controlled products
• Perform other tasks assigned by line manager

5) Compliance: all activities are compliance with local law and company policies and SOPs

Requirements:

• Education: Pharmacist
• Languages: Fluent in Vietnamese and English
• Experience: From 5 years of experience in Regulatory Affair role (Prefer in MNC);
• Proven experience with local submissions and communication with local authorities.