Responsible for defining regulatory strategies and submissions in supporting of new and existing marketing authorizations for products;
Responsible for acting in compliance with Vietnam policies and practices to reduce principal’s exposure to regulatory, quality and liability risks;
Accountable for relationship and communication with Regulatory Authorities;
Guide relationships with regulatory authorities to facilitate interactions on behalf of Principal/manufacturer for critical issues;
Set-up and develop and regulatory plans for complex projects including new projects and maintenance of existing marketing authorizations;
Suggest changes and finalize dossiers prepared at Head Office;
Lead the preparation of dossiers for visa in Vietnam;
Build, maintain Relationships with Government’s Quality Control Labs in Vietnam territory and following up testing results in Government’s QC Labs. Suggest the best suitable way to settle quality problems.
Bachelor degree in pharmacy/ medicine preferred.
Equivalents experience as Regulatory Affairs Manager in OTC Pharmaceutical sector.