Regulatory Pharmacist

PHILUSA Corporation; Pasig; On-site; PHP 334,800 - 558,000; Full time

Job summary

PHILUSA Corporation is seeking a regulatory professional in Pasig, Metro Manila to manage licenses and registrations under the FDA and global partners. Candidates must have a Bachelor's degree in Pharmacy and hold a Professional Regulation Commission License. Key responsibilities include the on-time submission of product registrations and ensuring compliance with safety and regulatory requirements. This role is essential for maintaining product standards and regulatory approvals.

Qualifications

• College graduate; Bachelor of Science in Pharmacy.
• Professional Regulation Commission License holder.
• Preferably, a holder of Qualified Person in Regulatory Affairs Accreditation (QPIRA).

Responsibilities

• Responsible for ensuring the establishment licenses and registrations of all products.
• On-time submission of initial, renewal, and variation of licenses and product registrations.
• Obtain on-time product registration approval from regulatory agency.

Skills

Regulatory compliance

Pharmacovigilance

Education

Bachelor of Science in Pharmacy

Professional Regulation Commission License

Qualified Person in Regulatory Affairs Accreditation (QPIRA)

Job description

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)