The Candidate Will Be Responsible For The Following
Responsible for ensuring the establishment licenses and registrations of all products under the Center for Device Regulation, Radiation Health, and Research (CDRRHR) and Center for Food Regulation and Research (CFRR) as well as comply with Pharmacovigilance requirements of FDA and global partners.
- On-time submission of initial, renewal and variation of licenses and product registrations
- Obtain on-time product registration approval from regulatory agency
- Compliance to Safety Data Exchange Agreement/PV
- Compliance/Audit Findings/ Post Licensing/ Post Marketing Surveillance
- Accomplish Special Projects SOP, Database, Product survey/testing
Must Also Meet The Following Qualifications
- College graduate; Bachelor of Science in Pharmacy
- Professional Regulation Commission License holder
- Preferably, a holder of Qualified Person in Regulatory Affairs Accreditation (QPIRA)
