Executive Regulatory Affairs (Healthcare)
Must-have:HealthTechLead
- Regulatory registration and product lifecycle management
- Lead the preparation, review, submission, and maintenance of product registration dossiers in compliance with applicable regulations.
- Develop and execute regulatory strategies for new product registrations, renewals, variations, and post-approval changes.
- Monitor registration timelines and ensure timely approvals from Health Authorities.
- Coordinate responses to regulatory inquiries and deficiency letters to facilitate product...
- Degree in Pharmacy or a related discipline
- Minimum 5 years of experience in Regulatory Affairs within the healthcare or pharmaceutical industry
- Strong knowledge of local regulatory requirements and Health Authority processes in Vietnam
- Fluent in English, both written and spoken
- Proficient in Microsoft Office applications including Excel, Word, and PowerPoint
- Strong communication, time...