Regulatory Affairs Executive
On-siteHanoi, Hanoi, Vietnam
Job Summary
Implement product registration strategies and handle registrations for assigned products while managing Regulatory Affairs to ensure compliance with statutory and company requirements. Network with key regulatory authorities to secure smooth approval processes and monitor the regulatory environment to develop appropriate responses. Act as the legally responsible person for company licenses and provide technical expertise to support sales and marketing activities. Submit PSUR/PBRER reports and convey license status changes to the PV department. Report to the Senior RA manager to execute regulatory activities and complete designated reports within timeframes.
Required Qualifications
- University Degree on Pharmacy/ Medicine
- At least 1-2 years of experience in regulatory function in the pharmaceutical industry
- Good written and oral communication skills in English
- Computer literate with proficiency in MS applications
- Full time
Desired Qualifications
- Proactive and highly committed to support and deliver results
- High Sense of Ownership and accountability for achievement
- Highly organized and self-disciplined
- Good interpersonal skills- capable of working and relating with competent authorities
- High level of integrity and good morals
- Innovative and resourceful with good analytical and problem-solving skills
- A good team player with good interpersonal skills
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