Regulatory Affairs Executive

Summary

The position resides in the Vietnam Region, Hanoi and is responsible for working with Global Regulatory Teams and head office-based team members to support RA function in the country .

Responsibilities

Primary responsibilities of this role include but are not limited to:

1. Responsible for all related regulatory activities in Vietnam from New filing to Lifecyle management activities
2. Provides direction for the activities related with assigned products. Works with Global Regulatory Teams (GRT)and head office-based team members ( e.g. Artwork team )and to support the regional and local strategy for assigned products.
3. Understands regional and local requirements and advises the Global Regulatory Team (GRT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables. Keeps up-to-date on understanding of regional/regulatory environment.
4. Provides inputs to submission tactical planning and timelines including lifecycle submissions (labeling changes, renewals and safety reports).
5. Responsible for communicating with the cross functional team and all the regulatory submission for Vietnam and submission dossier request has been submitted on the time
6. Ensure internal regulatory database/ system is properly updated and maintained.
7. Ensure that regulatory registration for Vietnam are submitted within company goal.
8. Responsible for the status for on-going regulatory registration for Vietnam until Lotus received the approval.
9. Ensure that all deficiency letters are properly and timely replied to have approved per the company goal.
10. To provide regulatory pathway and resolve regulatory related query to the cross functional department.
11. Responsible for review of artworks that are compliant with DAV requirements.
12. Manages regulatory interactions with DAV.

Qualifications

• Bachelor's degree in pharmacy
• Fluent in English
• 4+ years of relevant experience
• No disbarred from pharmaceutical operation
• Logic deducting ability
• Good computer skills
• Analytic Thinking
• Problem Solving
• Planning & Organizing
• Regulatory Strategy
• Project Management
• Influencing & Persuading Others