Regulation Affair Manager


Job description

  • 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.

Job Requirement

  • Bachelor degree in pharmacy/ medicine preferred.
  • Equivalents experience as Regulatory Affairs Manager in OTC Pharmaceutical sector.
  • Good command of English.


Required Job Skills

acting policies communication otc