Regulatory Affairs Executive
Core
Manage Regulatory Affairs for product allocation, ensuring compliance with statutory and company requirements while supporting business objectives in Vietnam.
Role type
Regulatory Affairs Executive
Builds
Product registration strategies and regulatory compliance for assigned pharmaceutical products
Domain
Pharmaceutical industry, Regulatory Affairs
Deliverable
client delivery
Required skills
Product registration strategy, regulatory authority networking, regulatory environment monitoring, SOP implementation, license management, pharmacovigilance reporting, sales and marketing support
Preferred skills
Strategic policy development, external consultant management, analytical problem-solving
Technologies
MS applications
Responsibilities
Implement product registration strategies, network with regulatory authorities, monitor regulatory environment and competitor activities, implement local regulatory SOPs, manage company regulatory licenses, support sales and marketing activities, submit PSUR/PBRER reports, convey license status changes to PV department
Seniority
Junior to Mid-level, hands-on IC
