Regulatory Pharmacist

Key Responsibilities

• FDA Product Registration: Manage the end-to-end preparation, submission, and tracking of Certificate of Product Registration (CPR) applications with the Philippine FDA.
• Licensing & Government Relations: Maintain and renew the company’s License to Operate (LTO) and serve as the primary contact for official regulatory correspondence.
• Labeling & Material Review: Review product packaging, labeling, and promotional artwork to ensure strict compliance with local FDA guidelines and global company standards.
• Compliance & Archiving: Maintain systematic regulatory document archives, monitor renewal timelines, and coordinate legal requirements (notarization, apostilles, and official payments).
• Administrative & Audit Support: Process government invoice payments, organize regulatory files, and ensure document readiness for external audits.

Requirements

Must-Have:

• Registered/Licensed Pharmacist in the Philippines with a valid PRC License.
• Minimum of 1–2 years of proven experience in Regulatory Affairs within the pharmaceutical or healthcare sector.
• Exceptional organizational, administrative, and document control skills with high attention to detail.
• Business-level English.

Nice-to-Have:

• In-depth working knowledge of Philippine FDA regulations, portal systems, and filing procedures.

Benefits & Perks

• Complete Philippine Statutory Benefits (SSS, PhilHealth, Pag-IBIG, 13th-Month Pay)
• Comprehensive HMO Coverage
• Performance-Based Company Bonus